Life Spine Initiates PROLIFT Lateral Expandable Outcomes Study
This is one of eight active studies underway to research the safety and efficacy of Life Spine's products.
Spinal Fusion
HAPPE Spine Gains Additional U.S. Patent
The patent claims provide broad protections for material and manufacturing that support fully porous, bioactive polyetheretherketone technology.
Spinal Elements Gains FDA Clearance of Sapphire X Anterior Cervical Fixation
While MIS procedures typically focus on incision size, MIS Ultra considers post-op implications such as disruption of skeletal and muscle tissue.
CoreLink Gains FDA Clearance of Stand-Alone Cervical System
F3D-C2 features the only 3D-printed technology with both a trabecular structure and directional support lattices.
SeaSpine Launches Mariner MIS and Outrigger Fixation
Combined with Midline and Adult Open systems, Mariner offers one product platform to perform open, MIS, hybrid, revision and adjacent segment procedures.
Orthofix Gains FDA Clearance for FIREBIRD SI Fusion
The 3D-printed bone screw is designed to relieve pain from sacroiliac joint dysfunction.
Xenco Launches CancelleX Titanium Foam Spine Implants
CancelleX bio-inspired spinal implants are the first injection-molded titanium foam implants for spine surgery pre-attached to disposable instruments.
Pantheon Surgical Acquires Blue Topaz, CompresSIve Technology
Pantheon Surgical acquired the technology from Osseus Fusion Systems, which will continue to distribute the Blue Topaz/CompresSIve system.
Carlsmed Raises Funds to Support aprevo System
The financing supports clinical launch of the aprevo system, which makes surgical plans and devices tailored to the needs of each patient.
SeaSpine Launches NorthStar OCT and Cervical Facet Fusion Systems
SeaSpine announced limited commercial launches and completion of initial surgeries with the NorthStar OCT and Cervical Facet Fusion systems.
joimax Partners with Distributor JAPAN MEDICALNEXT
JMC, located in Osaka, Japan, distributes orthopedic products with application in sports medicine, joint replacement, fracture fixation, etc.
NuVasive Launches Reline 3D for Pediatric Deformity
Reline 3D is designed to simplify spinal deformity procedures by allowing surgeons to drive simultaneous, three-dimensional correction.
icotec Gains Clearances for KONG VBR Spinal Systems
KONG-TL and KONG-C, featuring Titaniumcoating (Ti-iT®), received FDA 510(k) clearance in the U.S. and CE Mark approval in Europe.
Spinal Elements Introduces the MIS Ultra Platform of Products and Procedures
The MIS Ultra™ platform of products and procedures is designed to optimize spinal fixation and restoration and minimize unintended consequences of surgery.
Zavation Medical Launches Cortical Screw
The device is designed to achieve greater cortical bone purchase with a smaller midline incision when using Cortical Bone Trajectory.
Providence Medical Enrolls in FUSE IDE Study
FUSE is designed to demonstrate superiority of Circumferential Cervical Fusion vs. traditional ACDF in patients at high risk for nonunion or revisions.
MiRus Shares First Clinical Use of 3DR Printed Lumbar Interbody Fusion
The 3DR Printed Lumbar Interbody Fusion System is designed with a randomized lattice structure that mimics the organic structure of bone.
Augmedics xvision Used in First U.S. Spinal Fusion
Surgeons used the augmented reality system to visualize anatomy with simulated “x-ray vision” and to accurately guide instruments and implants.
4WEB Medical Gains FDA Clearance for Stand-Alone Anterior Lumbar Interbody Fusion
The company is expanding its Anterior Spine Truss System with the addition of integrated fixation.
OrthoPediatrics Launches ApiFix Deformity Correction
ApiFix provides options for the minimally invasive treatment of progressive adolescent idiopathic scoliosis in the U.S.
Precision Spine Launches Reform Ti Modular Pedicle Screw
The system offers options of increased flexibility, versatility and visibility in degenerative and trauma spinal procedures.
BRICON and PINA Medizintechnik to Merge
The companies' portfolios of cervical and lumbar spinal products are complementary. BRICON is based in Germany and PINA in Switzerland.
Patient Confidence Improving but Situation Remains Fluid
SI-BONE’s iFuse SI Fusion Implant Covered by Aetna
The positive coverage policy further validates acceptance of iFuse as a treatment option for patients with chronic sacroiliac joint dysfunction.
Medacta Announces First Surgery with Mecta-C Stand Alone Device and New Registrations
Mecta-C Stand Alone has also obtained CE Mark approval in Australia, and will soon be launched there and select areas in Europe.
Nexxt Spine Gains FDA Clearance for ALIF and Lateral Systems
ALIF launches August 2020 and Lateral in September 2020. An integrated plate system is slated for for each product in 4Q.
Life Spine’s First Cases with DYNA-LINK Ti Stand-Alone ALIF Spacer
DYNA-LINK Ti features the company's proprietary OSSEO-LOC™ surface technology and large, open graft windows.
Axis Spine Gains FDA Clearance for Axis-ALIF
Axis has developed a platform technology of build in situ modular cages as an alternative to conventional designs.
Zavation Medical Launches eZspand Expandable Cage
The lumbar interbody fusion device offers continual expansion to optimize the fit for each patient.
Precision Spine Launches the Reform Ti HA Coated Pedicle Screw
The system's screws feature a titanium tulip and a triple lead thread to offer strength and stability to all thoracolumbar constructs.
Neo Medical Raises Funding for Growth in Spinal Fusion
Neo Medical has developed a universal surgical platform, including five instruments and fourteen implants covering most spine indications.
Precision Spine Launches Slimplicity HP Anterior Cervical Plate
Precision Spine commenced U.S. launch of the Slimplicity® HP Anterior Cervical Plating (ACP) System, which accommodates diverse patient anatomies and pathologies with low profile constrained, semi-constrained or hybrid constructs....
NuVasive in Strong Position to Weather the COVID-19 Storm
Camber Spine Launches New Anterior Cervical Plates
The SPIRA-C Standalone Integrated Interbody and the FORTICO Anterior Cervical Plate are FDA 510(k)-cleared and ready for U.S. launch.
COVID-19 Derails SI-BONE’s Record Procedure Trajectory in 1Q20
NuVasive Expands Advanced Materials Science Implant Portfolio
The AMS implant portfolio includes proprietary surface and structural technologies to enhance biomechanical properties of materials for spine procedures.
Precision Spine Launches ShurFit 2C Interbody Systems
ShurFit 2C features a coating of titanium and hydroxyapatite to help increase durability support fixation during biologic fusion.
Life Spine Gains FDA Clearance for Additions to ARx
The clearance addresses implant and instrument additions to the system. ARx is Life Spine's fourth 510(k) clearance in 2020 with 92 total since inception.
Nanovis Awarded FDA Clearance for Nano FortiFix Pedicle Screw
This is the first pedicle screw system with a Nanotechnology designation and osteoblast/stem cell data comparing performance to other surface types.
Atlas Spine Gains FDA Clearance for Expandable Stand-Alone Cervical Interbody
HiJAK SA joins first-to-market HiJAK AC and the V3 segmental plating system as the latest technology in Atlas Spine's disruptive design portfolio.
Spineway Signs Exclusive Contract with MURANAKA Medical Instruments
With this agreement, Spineway can deploy its implants in one of the largest markets in spine and accelerate its sales with higher added value.
Life Spine PROLIFT Lateral Fixated System Gains FDA Clearance
The system is complemented by Life Spine's full Lateral portfolio including the CENTRIC® Plier Style Retractor and Lateral Disc Prep.
Precision Spine Launches Reform MC Posterior Lumbar Fusion System
The Reform MC is a top-loading, multiple component, posterior spinal fixation system with cannulated pedicle screws, straight and lordotic rods and locking cap screws.
DePuy Synthes Down 7.5%, Bracing For More Extreme Declines
Hyprevention Receives FDA Clearance for V-STRUT Vertebral Implant
With the V-STRUT system, two PEEK polymer implants are inserted in the vertebral body through the pedicles and combined with PMMA bone cement to treat VCFs.
Signus Medizintechnik Gains CE Mark for BIG ST ALIF Cage
Signus Medizintechnik announced CE Mark approval for the BIG® ST ALIF Cage and JASPIS® ST Cervical Cage, additions to the company's Structural Titanum portfolio of 3D-printed cages.
Precision Spine Launches Reform Ti Titanium Pedicle Screw
Precision Spine globally launched the Reform® Ti Titanium Pedicle Screw for degenerative and trauma spine procedures.
NuVasive Issues Field Safety Notice for MAGEC System
NuVasive voluntarily issued an Urgent Field Safety Notice in the U.K. and Ireland to address concerns identified by The Medicines and Healthcare Products Regulatory Agency over continued use of the MAGEC device for the treatment of scoliosis.
Nexxt Spine Launches Nexxt Matrixx Corpectomy
Nexxt Spine received FDA 510(k) clearance of the Nexxt Matrixx® Corpectomy System, and commenced product launch.
Safe Orthopaedics Gains Japan Approval of Next-Gen SteriSpine PS
Safe Orthopaedics received regulatory approval of SteriSpine™ PS 2nd Generation in Japan.
OrthoPediatrics Gains Expanded Indications for RESPONSE Scoliosis System
OrthoPediatrics was granted FDA 510(k) clearance to expand indications for the RESPONSE™ Scoliosis System to include neuromuscular implants.
Safe Orthopaedics’ Key Patents Confirmed in Europe
The European Patent Office confirmed the strength of certain of Safe Orthopaedics' patents following an opposition procedure by Neo Medical.
Alpha Launch of ChoiceSpine’s RAVEN Lateral Lumbar Plate
ChoiceSpine commenced alpha release of the RAVEN™ Lateral Lumbar Plate.
Precision Spine Launches SureLOK MIS 3L Percutaneous Screw
Precision Spine commenced U.S. launch of the SureLOK™ MIS 3L Percutaneous Screw.
SI-BONE Double Digit Growth Fueled by Reimbursement Wins
NuVasive Attrax Putty Study Results
Study results support the use of NuVasive's Attrax® Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion.
ATEC Outperforms Expectations With 24% Growth In 2019
Medacta Gains FDA Clearance for Mecta-C Stand Alone ACIF Implant
Medacta received FDA 510(k) clearance to market the Mecta-C Stand Alone Implant.
Life Spine Gains Additional FDA 510(k) for Lateral PROLIFT Expandable System
Life Spine received an additional FDA 510(k) clearance for the Lateral PROLIFT® Expandable System.
Amplify Surgical Announces 300th Level Treated with dualX Expanding Interbody
Amplify Surgical's dualX™ Expanding Interbody Fusion System has been implanted in 300 surgical levels to date. Initial alpha launch commenced in 1Q19.
AO Foundation and icotec Developing Spinal Stabilization
The AO Foundation and icotec will jointly develop a new spinal stabilization system based on icotec's BlackArmor® Carbon/PEEK composite material.
ATEC to Acquire EOS imaging
Alphatec/ATEC entered into an agreement to acquire EOS imaging for nearly USD $122 million in cash and equity. The transaction is slated to close in 3Q20.
RTI Surgical SImmetry System Interim Study Results
RTI Surgical's SImmetry® sacroiliac fusion system yielded evidence of fusion in 98% of treated joints, per interim study results.
NuVasive Hits $1 Billion in Spine Sales for 2019
Globus Notches Third Straight Year of Double-Digit Growth in 2019
restor3D Raises $4.3 Million in Equity Funding
restor3D raised USD $4.4 million in equity. The company develops 3D-printed implants, and entered into a development and licensing agreement with SeaSpine in late 2019.
Genesys Spine Launches Sacroiliac Joint Fusion System
Genesys Spine introduced its Sacroiliac Joint Fusion system, which gained FDA 510(k) clearance in 3Q19.
Late-Quarter Infuse Headwinds Blunt Medtronic’s Growth
Medicrea Gains FDA Clearance for Patient-Matched Interbody Cages
Medicrea was granted FDA 510(k) clearance for UNiD® IB3D Patient-Matched interbody cages.
INSPAN Reports Study Results from Inspan Interspinous Fixation Device
INSPAN announced successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan® ScrewLES™ Fusion interspinous fixation device.
CTL Amedica Granted Patent for Screw Offset Blocking Mechanism Used in MONET Anterior Cervical Fusion
CTL Amedica was granted a U.S. patent addressing a screw offset blocking mechanism that is used in the company's MONET™ Anterior Cervical Fusion System.
Tenon Medical’s Catamaran SI Fixation Study Results
Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System demonstrated an over 85% reduction in SIJ pain at six weeks, with radiographic evidence of solid continuous bridging bone across the treated joint at six months.
Life Spine Gains FDA Clearance of Steerable PLATEAU Ti Interbody
Life Spine gained FDA 510(k) clearance for the Steerable PLATEAU® Ti System.
Globus Medical’s First Case with HEDRON IA ALIF Spacer
Globus Medical announced the first implantation of HEDRON IA, a 3D-printed integrated anterior lumbar interbody fusion spacer.
Medicrea Reaches 5,000 Cases with UNiD ASI Technology
Medicrea achieved the milestone of more than 5,000 procedures using the UNiD® ASI platform and patient-specific spinal implants.
Osseus Fusion Debuts Aries-TS TLIF Device
Osseus Fusion Systems commenced alpha launch of the Aries™-TS 3D-printed transforaminal lumbar interbody fusion device.
SpineCraft Launches ASTRA OCT Spine System
SpineCraft completed the ASTRA product platform with launch of its Occipito-Cervico-Thoracic system for use in posterior cervical fusion.
Atlas Spine Launched V3 Guided Segmental Cervical Plate
Atlas Spine launched the V3 Guided Segmental Plating System to treat complex deformity and degenerative conditions of the cervical spine.
DePuy Synthes Accelerates Commitment to Digital Surgery in 2020
Inspired Spine Reaches 1,000 OLLIF Procedure Milestone
Inspired Spine achieved the milestone of completion of 1,000 Oblique Lateral Lumbar Interbody Fusion procedures.
CoreLink Hits Milestone of 5,000 Implants with 3D-Printed Technology
CoreLink has implanted over 5,000 3D-printed spinal devices that employ proprietary Mimetic Metal® additively-manufactured technology.
Cutting Edge Spine Gains FDA Clearance of EVOLha-DLIF
Cutting Edge Spine received FDA 510(k) clearance of the EVOL®ha-DLIF direct lateral interbody fusion system.
Medicrea Awarded 7 New U.S. Patents
Medicrea was issued seven additional U.S. patents related to its proprietary UNiD™ Adaptive Spine Intelligence technology platform.
SeaSpine Launches Mariner Midline Posterior Fixation
SeaSpine commenced the full commercial launch of the Mariner® Midline Posterior Fixation System, a less-invasive option to treat a range of spinal pathologies.
SeaSpine Marks 25,000th NanoMetalene Implantation
SeaSpine announced the implantation of the 25,000th NanoMetalene® interbody device.
Study Results: RTI Surgical’s TETRAfuse 3D PEKK Technology
Studies show that RTI Surgical's TETRAfuse® PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time and a significantly higher push-out strength vs. standard PEEK.
Curexo Launches Robot-Assisted Spine Surgery Device
Curexo launched the CUVIS-spine robot-assisted spine surgery device in Korea.
CIGNA Establishes Positive Coverage for MIS SI Joint Fusion
CIGNA announced a positive coverage policy for minimally invasive sacroiliac joint fusion exclusive for FDA-cleared implants that are placed across the SI joint, such as SI-BONE's iFuse Implant System.
ulrich medical USA Launches Momentum Posterior Spinal Fixation
ulrich medical USA launched the Momentum™ Posterior Spinal Fixation System.
Medtronic Introduces Mazor X Stealth Edition in India
Medtronic launched the Mazor X Stealth Edition™ Robotic-Assisted Spine Surgery System in India.
ATEC Launches SafeOp Neural InformatiX System
ATEC Spine commenced full commercial launch of the SafeOp Neural InformatiX System™.
Aurora Spine Sales Decline on Product Line Cannibalization
Life Spine Gains FDA Clearance for LONGBOW Titanium Spacer
Life Spine was granted FDA 510(k) clearance to market the LONGBOW® Titanium Lateral Expandable Spacer.
Entry Into Joint Replacement a Major Step in Globus Medical’s Evolution
NuVasive Gains Additional FDA Clearance for CoRoent Small Interlock
NuVasive received FDA 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system.
DePuy Synthes Launches SYMPHONY OCT System
DePuy Synthes launched the SYMPHONY Occipito-Cervico-Thoracic System, expanding its offering for the treatment of conditions in the neck and upper spine.
4WEB Medical Launches Stand Alone Cervical Spine Truss
4WEB Medical commenced limited launch of the Cervical Spine Truss System-Stand Alone™ (CSTS-SA) implant.
Medtronic’s Surgical Synergy Strategy Accelerates Growth in Spine
Life Spine’s CENTERLINE Modular Spinal System in Limited Launch
Life Spine commenced limited launch of the CENTERLINE® Modular Thoracolumbar Spinal System, and announced initial surgeries. Full launch is slated for early 2020.
Medicrea Growth Driven by U.S. Sales of Patient-Specific Implants
Globus Medical Double-Digit Growth Driven by Spinal Hardware and ExcelsiusGPS
Zimmer Biomet Gains Momentum on ROSA Knee and Increased Supply
CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion
CMS increased the Medicare Physician Fee Schedule for CPT® Code 27279, Arthrodesis Sacroiliac Joint, under which minimally invasive sacroiliac joint fusion procedures are reported.
RTI Surgical Reduces Guidance Due to Softer than Expected coflex Sales
Spineology U.S. Fusion Trial 24-Month Outcomes Data
Two-year outcomes from Spineology's SCOUT trial of the OptiMesh® device revealed substantial improvements in low back pain and function scores at 6, 12 and 24 months.
DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial
DiFusion received FDA 510(k) clearance for the Xiphos-ZF spinal interbody device made from ZFUZE biomaterial. Product launch will occur within 4Q19.
U.S. Spinal Hardware Sales Continues to Drive NuVasive Growth
Alphatec Spine Continues Success Story with New Product Launches and a Revitalized Sales Channel
Spinal Implant Growth Drives SeaSpine to Record Revenues
Stryker Gains FDA Clearance for SAHARA Lateral 3D Expandable Interbody
Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.
Safe Orthopaedics SteriSpine LC and CC Gain Japan Regulatory Approval
Safe Orthopaedics received regulatory approval for SteriSpine™ LC lumbar and CC cervical cages in Japan.
Nanovis Gains FDA Clearance for Bioceramic Nanotube Surface
Nanovis received the first FDA 510(k) clearance for a bioceramic nanotube surface that demonstrates FDA's requirements for nanotechnology.
Implanet Granted Patent in Japan for JAZZ Lock
Implanet was granted a patent in Japan for JAZZ Lock® technology, part of its JAZZ™ solutions platform to treat degenerative spine disorders.
Alphatec Launches IdentiTi for Lateral Interbody Fusion
Alphatec launched IdentiTi™ porous titanium implants for lateral interbody fusion procedures.
CarboFix Gains FDA Clearance for Carbon Fiber VBR
CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber Vertebral Body Replacements.
DePuy Synthes Up 1.2% in 3Q19 on Trauma Growth
Spineway Mont Blanc MIS Approved in Japan
Spineway obtained regulatory approval in Japan for its Mont Blanc minimally invasive surgical devices.
Zimmer Biomet Launches TrellOss-TC Porous Titanium Interbody System
Zimmer Biomet launched the TrellOss™-TC Porous Titanium Interbody, completing its initial offering of porous titanium implants.
HD LifeSciences Announces Fluid Channels Patent Allowance
HD LifeSciences received a patent allowance notice addressing fluid channel technology employed in its interbody fusion devices.
Aegis Spine Gains FDA Clearance for AccelFix Expandable Cage
Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage System.
Viseon’s First Clinical Use of Voyant Lateral System
Viseon announced the first clinical use of Voyant Lateral visualization to support real-time imaging during a minimally invasive lateral lumbar procedure.
Amplify Surgical Announces 100th Level Treated with dualX Expanding Interbody
Amplify Surgical marked the milestone of 100 surgical levels implanted with the dualX™ Expanding Interbody Fusion System.
Spineology Raises $7MM in Equity
Spineology raised $7MM of a potential $16MM round of equity funding.
Back 2 Basics Gains FDA Clearance for Carbon Interbody Cages
Back 2 Basics received FDA 510(k) clearance to market eCarbon anterior cervical and posterior lumbar Interbody devices.
Alphatec Up 24% in 2Q19 on Revitalized Sales Channel
SeaSpine Announces 20,000th NanoMetalene Implantation
SeaSpine marked the implantation of the 20,000th NanoMetalene® interbody device.
MiRus Gains FDA Clearance for CYGNUS Anterior Cervical Plate
MiRus received FDA 510(k) clearance to market the molybdenum alloy-based CYGNUS Anterior Cervical Plate.
Life Spine Gains Additional FDA 510(k) Clearance for PROLIFT Expandable Spacer
Life Spine received an additional 510(k) market clearance from FDA for the PROLIFT® Expandable Spacer System, addressing new sizes.
The Spine Market: A Look at Past and Forecasted Performance
Spine is the largest individual segment that we track, accounting for 18.2% of the orthopedic industry's overall revenue. Excluding biologics, sales of orthopedic spine products topped $9.3 billion in 2018, growing +2.7% vs. 2017. Growth in the segment exceeded our expectations, as several companies in the top 10 posted double-digit increases that offset lower performance by manufacturers at the top of the list. Here, we take a deeper look at past, present and forecasted performance.
FDA 510(k) Recap: Spinal Devices and Technologies from 1H19
With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.
NanoFUSE Launches NanoSTRIP 100% Bioactive Glass Synthetic Biologic
NanoFUSE commenced market release of NanoSTRIP, a 100% bioactive glass synthetic biologic strip indicated for spine and orthopedic use.
Centinel Spine Successfully Surpasses 1,000 Implantations with FLX Interbody Devices
Centinel Spine announced 1,000 implantations of FLX 3D-printed porous titanium interbody devices since initial launch in 3Q18.
Alphatec Launches InVictus Spinal Fixation
Alphatec commenced commercial release of InVictus, a spinal fixation platform to treat a range of pathologies via MIS, open or hybrid surgical approaches.
Alphatec Launches IdentiTi Interbody for ALIF
Alphatec commenced commercial release of the IdentiTi Large Window Porous Titanium Interbody Implant for anterior lumbar interbody fusion.
joimax Launches EndoLIF Line
joimax commenced launch of the complete line of EndoLIF® devices for lumbar interbody fusion.
Osseus Fusion Systems Acquires SIJ Surgical
Osseus Fusion Systems acquired SIJ Surgical, developer of a sacroiliac fusion screw.
Safe Orthopaedics’ SteriSpine Used in First Surgeries in Japan
Safe Orthopaedics' SteriSpine pedicle screw kits have been utilized in 23 procedures in Japan since launch in May 2019.
SeaSpine Launches Regatta Lateral System
SeaSpine commenced full launch of the Regatta® minimally invasive lateral interbody fusion system.
Implanet reports 2Q19 revenue of €1.9MM (USD $2.2MM), +8.4% vs. 2Q18
icotec Gains FDA Clearance for VADERone Pedicle Screw
icotec was granted FDA 510(k) clearance for VADER®one pedicle screws for minimally invasive and open spine procedures.
Celling Spine Acquires Assets of Link Spine
Celling Spine acquired all assets of Link Spine, and will develop spinal fusion hardware to complement its own orthobiologic product portfolio.
Medtronic Completes Acquisition of Titan Spine
Medtronic closed its acquisition of Titan Spine, developer of Endoskeleton® interbody devices and nanoLock® surface technology.
SI-BONE’s iFuse Surpasses 40,000 Procedures
SI-BONE's iFuse Implant System®, introduced in 2009, has been used in >40,000 SI joint fusion procedures by more than 1,900 surgeons worldwide.
Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody
Benvenue Medical received FDA 510(k) clearance for the Luna® XD MIS expandable interbody device. Controlled launch will proceed at select centers.
Innovasis Gains FDA Clearance of LxHA Spinal Fusion System
Innovasis was granted FDA 510(k) clearance to market the LxHA Lateral Interbody Fusion Device.
Implanet Books First Orders Supporting Kico Knee and SeaSpine Partnerships
Implanet received its first orders related to its distribution agreements with Kico Knee Innovation and SeaSpine.
Life Spine Gains FDA Clearance for PROLIFT Lateral Expandable Spacer
Life Spine received FDA 510(k) clearance to market the PROLIFT® Lateral Expandable Spacer system.
NuVasive Launches Modulus TLIF-O Porous Titanium Spine Implant
NuVasive commenced launch of Modulus® TLIF-O, a porous titanium implant for transforaminal lumbar interbody fusion.
Medicrea Awarded Additional U.S. Patents
Medicrea was allowed three new U.S. patents relating to the company's proprietary UNiD® Adaptive Spine Intelligence software platform.
ulrich medical USA to Surpass 100,000 VBR Implant Milestone in 2019
ulrich medical USA is slated to achieve the milestone of 100,000 total vertebral body replacement device implantations within the year.
RTI Surgical Milestone for Fortilink Interbody Fusion Systems
RTI Surgical achieved the milestone of 5,000 implants of Fortilink®-C, -TS and -L interbody fusion systems in the U.S.
Implanet Announces First U.S. JAZZ Cap Procedures
Implanet's JAZZ® Cap device has been successfully used in first U.S. spinal fusion procedures.
Zavation Receives FDA Clearance for Ti3Z Interbody
Zavation received FDA 510(k) clearance to market the Ti3Z lumbar interbody system.
Ozop Surgical Update on Adjustable ALIF Interbody Implant
Ozop Surgical has completed initial testing of a novel adjustable ALIF interbody spinal implant.
Globus Medical Launches AERIAL Expandable Interspinous Fixation
Globus Medical introduced AERIAL, a minimally invasive expandable interspinous fixation system.
Aurora Spine Reports 1Q19 Revenue of $2.7MM, +81.2% vs. 1Q18
Alphatec Launches TLIF IdentiTi Posterior Curved Porous Titanium Interbody
Alphatec launched the IdentiTi-PC Porous Titanium Interbody Implant for TLIF.
Medtronic Reports FY 4Q19 Orthopedic Revenue of $862.9MM, +4.9% vs. 4Q18
Camber Spine Announces 1Q19 Sales Results +22% vs. 1Q18
M&A Recap: Three 2Q Announcements in Spine
Of the 20 OEM-related M&A announcements we've covered in 2019 thus far, seven have related to the spine market. Of those, three were announced in rapid succession within this quarter. Let's see who bought whom, and what they got: Medtronic/Titan Spine, Boston Scientific/Vertiflex and WishBone Medical/CSpine.
CoreLink Launches Lateral Access and Interbody Fusion Platform
CoreLink introduced a lateral access and interbody fusion platform comprising tissue retractor options and F3D titanium alloy and CL5 PEEK lateral interbody implants.
Alphatec Spine Reports 1Q19 Revenue of $24.6MM, +15.3% vs. 1Q18
Innovasis HA PEEK Data Registry Reaches Milestone of 150 Enrollees
Innovasis' HA PEEK Data Registry achieved significant enrollment of 150 patients since its 2018 launch.
ChoiceSpine Gains FDA Clearance for Two Cervical Spinal Fusion Devices
ChoiceSpine received FDA 510(k) clearance to market the TIGER SHARK C interbody device and the BOOMERANG Anterior Cervical Plate.
SI-BONE Reports 1Q19 Revenue of $15MM, +17.9% vs. 1Q18
Medtronic Enters Agreement to Acquire Titan Spine
Medtronic entered into a definitive agreement to acquire Titan Spine, a titanium spine interbody implant and surface technology company.
WishBone Medical Acquires CSpine
WishBone Medical purchased CSpine, manufacturer of spine and orthopedic implants and instruments.
Globus Medical Reports 1Q19 Revenue of $182.9MM, +4.9% vs. 1Q18
NuVasive Reports 1Q19 Revenue of $274.8MM, +5.5% vs. 1Q18
Alphatec Launches PLIF IdentiTi Posterior Straight Interbody and AlphaGRAFT DBM Fiber
Alphatec launched the PLIF IdentiTi-PS Porous Titanium Interbody for PLIF, and AlphaGRAFT® DBM Fiber.
SeaSpine Reports 1Q19 Revenue of $36.2MM, +9% vs. 1Q18
Aurora Spine Reports 4Q18 Revenue of $2.5MM, +82.4% vs. 4Q17
ApiFix Completes Series B Financing
ApiFix completed its Series B financing round and is preparing for U.S. commercial launch of its MID-C System to treat pediatric scoliosis.
Safe Orthopaedics’ SteriSpine PS Gains Japan Regulatory Approval
Safe Orthopaedics received regulatory registration in Japan for the SteriSpine PS system to treat spinal fractures.
NuVasive Cohere Porous PEEK Comparative Study Results
NuVasive's Cohere® Porous PEEK interbody demonstrated clear benefits in promoting improved early outcomes in ACDF procedures when compared to both structural allograft and smooth PEEK.
SI-BONE Gains FDA Clearance of iFuse Bedrock Fixation Technology
SI-BONE received an additional FDA 510(k) clearance for use of iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.
Medicrea Reports 1Q19 Revenue of €7.7MM, +10.6% vs. 1Q18
NuVasive Debuts X360 System for Lateral Single-Position Spine Procedures
NuVasive is introducing the X360 system integrated with Pulse automation for lateral single-position surgery.
NASS Review: Spinal Robotics, Enabling Technologies, 3D Printing and Biologics
Enabling technology was the story of the North American Spine Society 2019 annual meeting (NASS), with the top spine players heavily featuring their robotic-assisted surgery ecosystems.
ChoiceSpine HAWKEYE Ti VBR Cleared for All Spine Segments
ChoiceSpine received expanded FDA 510(k) clearance for the HAWKEYE Ti vertebral body replacement for use in the cervical spine.
NuVasive Proprietary Porous PEEK Used In First XLIF Cases
NuVasive announced initial XLIF® spinal procedures using the Cohere® XLIF lateral Porous PEEK device.
Alphatec Launches IdentiTi Porous Titanium Interbody Cage
Alphatec announced commercial release of the IdentiTi-C Porous Titanium Interbody for ACDF.
SpineEX Issued New U.S. Patent
SpineEX was issued its second U.S. patent, addressing a novel mechanism to adjust posterior and anterior sides of an interbody fusion device independently of each other.
MiRus Gains FDA Clearance for Molybdenum Rhenium Pedicle Screw
MiRus received FDA 510(k) clearance for the Europa pedicle screw made of MoRe® molybdenum rhenium superalloy material.
SpineEX Receives Additional FDA Clearance for Sagittae LLIF
SpineEX gained additional FDA clearance for the Sagittae Lateral Lumbar Interbody Fusion system, covering new instrumentation and an updated surgical technique.
RTI Surgical Enrolls 1st Patient in FORTE Clinical Study of Fortilink Interbody
RTI Surgical enrolled the first patient in FORTE, a clinical evaluation of the Fortilink® interbody fusion device in the treatment of degenerative disc disease. Enrollment is slated for completion in 1Q20.
Implanet Gains FDA Clearance for JAZZ Cap
Implanet received FDA 510(k) clearance to market JAZZ Cap® to secure screws in poor quality bone in vertebral fusion procedures.
iOrthopedics Introduces the Gobi Expandable Spine Cage
iOrthopedics introduced the Gobi Spine Cage, evolving from its Uniformly Expanding Cage patents toward 50% expansion uniformly, proximally or distally.
Kuros Biosciences Gains FDA Clearance for Intervertebral Body Fusion Device
Kuros Biosciences received FDA clearance to market the Kuros TLIF cage.
SI-BONE reports 4Q18 revenue of $15.6MM, +13% vs. 4Q17
Amplify Surgical’s dualX Dual Expanding Interbody Fusion Used in First Cases
Amplify Surgical completed initial surgical cases with the dualX Dual Expanding Interbody Fusion System.
SeaSpine Reports 4Q18 Revenue of $38MM, +11.9% vs. 4Q17
Atlas Spine Launches HiJak AC Expandable Interbody
Atlas Spine announced successful completion of its 50th surgical procedure and >100 devices implanted with the HiJak AC expandable cervical interbody fusion device.
4WEB Medical Expands Surgeons Users by 20%
Alphatec Gains FDA Clearance for SafeOp Neuromonitoring
Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.
Safe Orthopaedics Launches Essential Instrument Kit
Safe Orthopaedics launched Essential, a kit containing all of the instruments needed to perform a percutaneous spinal fracture repair.
OrthoPediatrics Launches BandLoc DUO
OrthoPediatrics introduced BandLoc DUO, the latest addition to the BandLoc 5.5/6.0mm spinal repair system.
NuVasive Reports 4Q18 Revenue of $288.3MM, +6.3% vs. 4Q17
Globus Medical Reports 4Q18 Revenue of $195.9MM, +11.3% vs. 4Q17
SeaSpine, Implanet Form US Partnership with Jazz Spinal Devices
Implanet entered into a U.S. private label distribution agreement with SeaSpine covering the Jazz® portfolio of spinal devices.
SpineGuard Achieves DSG Technology Milestone
SpineGuard marked the 70,000th spinal procedure using DSG® real time digital technology for surgical guidance.
Medtronic Reports FY 3Q19 Orthopedic Revenue of $739.8MM, -0.3% vs. 3Q18
Carevature Completes 1,000 Procedures with Dreal Technology
Carevature Medical achieved a milestone of 1,000 procedures using the Dreal® decompression platform.
Life Spine Launches SIMPACT SI Joint Fixation Study
Life Spine initiated an outcomes study for SIMPACT® Sacroiliac Joint Fixation.
Alphatec Announces Stay of Proceedings In NuVasive Patent Lawsuit
Alphatec announced favorable developments in its ongoing patent litigation with NuVasive regarding CoRoent® lateral implants.
iOrthopedics: Patents Expected for 3D Printing of Universally Expanding Cage
iOrthopedics continues to expand its IP portfolio, with pending patents directed to methods of 3D printing its Universally Expanding Cage interbody device.
Southern Spine Launches Thoracic Dual Lamina Implants for StabiLink Interlaminar System
Southern Spine commenced full launch of three StabiLink® Dual Lamina implants, designed for upper thoracic procedures. The company also announced three additional U.S. patents for its StabiLink® MIS Interlaminar Spinal Fixation System.
Spineart’s 1,000 Perla Posterior Cervical Surgery
Spineart reached the milestone of 1,000 Perla procedures performed in the U.S.
Aesculap Implant Systems PlasmaporeXP Surface Enhancement Study
Studies of Aesculap Implant Systems' Plasmapore®XP Surface Enhancement indicate that early bone-forming activity was upregulated in osteoblast-like cells that attached to the PlasmaporeXP.
Aurora Spine Granted U.S. Patent for Minimally Invasive Spinal Devices
Aurora Spine was granted a U.S. patent, œExpandable Interspinous Device, covering the company's family of minimally invasive spinal implants.
DePuy Synthes Reports 4Q18 Revenue of $2,205.1MM, -0.5% vs. 4Q17
Medicrea Reports 4Q18 Revenue of €8MM, +33.3% vs. 4Q17
Centinel Spine Completes Initial Cases Using FLX 3D Printed Lateral Lumbar Interbody System
Centinel Spine has completed initial procedures with its newest implant system in the FLX platform of Integrated Interbody 3D-printed interbody fusion devices.
HoloSurgical’s ARAI Used in Spinal Fusion Procedure
HoloSurgical announced a successful first in human procedure utilizing the ARAI augmented reality and artificial intelligence-based navigation system.
SpineSource Acquires Implant Systems from Kisco
SpineSource acquired the IP assets of two spinal implant systems from Kisco International, including the L-VARLOCK® expandable lumbar cage.
ulrich medical USA Launches Solidity Expandable VBR
ulrich medical USA announced U.S. launch of the Solidity expandable vertebral body replacement.
Spineology Duo LIF Commercial and Postmarket Update
Spineology surpassed completion of 125 lateral interbody fusion cases with the Duo system.
Medtronic Completes Acquisition of Mazor Robotics
Medtronic completed its planned acquisition of Mazor Robotics in a transaction valued at US $1.7BB.
OrthoPediatrics’ Launch of RESPONSE 4.5/5.0mm System
OrthoPediatrics commenced full U.S. launch of the RESPONSE 4.5/5.0mm system for the treatment of complex scoliosis.
NuVasive Gains FDA Clearance for Monolith Corpectomy
NuVasive received FDA 510(k) clearance to market an expanded indication for the Monolith® corpectomy system in the cervical spine.
ZygoFix Launches zLOCK Facet Fixation Study
ZygoFix announced the successful start of a first in human clinical study of zLOCK facet joint fixation.
Blue Cross Blue Shield of Arizona Covers SI BONE iFuse Implant System
SI-BONE's iFuse Implant System received exclusive coverage from Blue Cross Blue Shield of Arizona.
Nexxt Spine Launches SAXXONY Posterior Cervical Thoracic System
Nexxt Spine grows its fusion portfolio with launch of the SAXXONY® Posterior Cervical Thoracic system.
SI-BONE reports 3Q18 revenue of $13.4MM, +14.5% vs. 3Q17
Safe Orthopaedics Study: Cost Savings with Single-use Instruments
Study results revealed an average 50% cost-per-patient savings with use of Safe Orthopaedics' instruments vs. reusable ones in the treatment of spinal fractures.
Zimmer Biomet Recalls Spinal Fusion and Long Bone Stimulators
Zimmer Biomet initiated a recall of 1,360 units of the Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator and SpF-XL Implantable Spinal Fusion Stimulator devices.
ChoiceSpine Acquired by Altus Capital
ChoiceSpine, a manufacturer of devices and biologics used to treat complex spine disorders, was acquired by Altus Capital Partners.
Medicrea Reports 3Q18 Revenue of €7.3MM, +14.1% vs. 3Q17
HealthPartners Covers RTI’s SImmetry SI Joint Fusion
HealthPartners, the largest consumer-governed nonprofit healthcare organization in the U.S., issued a positive coverage decision for minimally invasive sacroiliac joint fusion surgery, expanding patient access to RTI Surgical's SImmetry System.
Aurora Spine Gains Access to SI Fusion Patent
Aurora Spine acquired an exclusive license to a U.S. patent pertinent to sacroiliac joint repair.
NuVasive Launches Brigade for ALIF Surgery
NuVasive announced U.S. commercial launch of the Brigade® Lateral device for lateral anterior lumbar interbody fusion.
Camber Spine: First Procedures with ENZA-A Titanium ALIF
Camber Spine successfully completed its first procedures with the ENZA-A Titanium Anterior Lumbar Interbody Fusion system.
Bio2 Gains Approval to Study Vitrium in Interbody Fusion
Bio2 Technologies received FDA approval to enroll subjects in an IDE clinical study of Vitrium bioactive glass as a cervical interbody fusion device.
Alphatec Spine Reports 3Q18 Revenue of $23MM, -0.4% vs. 3Q17
Globus Medical Reports 3Q18 Revenue of $169.2MM, +11.5% vs. 3Q17
K2M Reports 3Q18 Revenue of $71.4MM, +13.9% vs. 3Q17
SeaSpine Reports 3Q18 Revenue of $35.8MM, +12.9% vs. 3Q17
NuVasive Gains FDA Clearance for COHERE in XLIF
NuVasive received FDA 510(k) clearance for the COHERE® Porous PEEK device in eXtreme Lateral Interbody Fusion.
Stryker Completes K2M Acquisition
Stryker closed the previously-announced $1.4BB acquisition of K2M.
Spinal Elements Receives Additional FDA 510(k) Clearance for Ti-Bond Coating Technology
Spinal Elements received additional FDA 510(k) clearance for claims related to the macro-, micro- and nano-surface structure of its Ti-Bond® surface coating technology.
iOrthopedics Awarded Additional Patent for Universally Expanding Cage
iOrthopedics was granted U.S. Patent No. 10,085,846 for its Universally Expanding Cage interbody device.
OrthoPediatrics Reports 3Q18 Revenue of $15.8MM, +27.8% vs. 3Q17
RTI Surgical Acquiring Paradigm Spine
RTI Surgical entered into a definitive agreement to acquire Paradigm Spine in a cash and stock transaction valued at up to US $300MM.
Innovasive Gains FDA Clearance for DualX Expanding Interbody
Innovasive received FDA 510(k) clearance to market the DualX titanium dual expanding interbody device for lumbar fusion procedures.
NuVasive Reports 3Q18 Revenue of $271.3MM, +9.6% vs. 3Q17
Orthofix Reports 3Q18 Revenue of $111.7MM, +6.1% vs. 3Q17
Life Spine’s First Clinical Cases with PROLIFT Post Pack Expandable Interbody
Initial clinical cases have been performed with Life Spine's PROLIFT® Post Pack expandable interbody system.
Camber Spine Reaches $1MM Milestone with SPIRA-C
Aurora Spine Granted EU Patent for ZIP Minimally Invasive Spinal Devices
Aurora Spine was granted an EU Patent covering ZIP® interspinous devices.
SI-BONE Closes Initial Public Offering
SI-BONE closed its previously-announced initial public offering of 8,280,000 shares of common stock, priced at US $15 per share. The company is now trading on Nasdaq with the ticker symbol SIBN.
OrthoPediatrics Gains FDA Clearance for Small Stature Scoliosis System
OrthoPediatrics received FDA 510(k) clearance to market the RESPONSE 4.5/5.0mm system to treat complex scoliosis in smaller stature patients.
K2M Expands MESA Platform with FDA Clearance for Sagittal Imbalance Application
K2M received additional FDA 510(k) clearance for the MESA® Spinal System, supporting use of sagittal plane correction in idiopathic scoliosis.
SpineEX Gains FDA Clearance for Sagittae LLIF
SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar interbody fusion.
NuVasive Enters Partnership with Biedermann Technologies
NuVasive entered into a strategic partnership with Biedermann Technologies to integrate proprietary screw technology into NUVA's RELINE® portfolio, for 1H19 launch.
Safe Orthopaedics Posts 3Q18 Revenue Growth of 20%
ApiFix System Reaches 250-Patient Milestone in Scoliosis Correction
The ApiFix Minimally Invasive Deformity Correction (MID-C) technology for correction of Adolescent Idiopathic Scoliosis has been used in 250 patients to date.
SI-BONE Announces UK Guidance Recommendation for iFuse
The U.K.'s National Institute for Health and Care Excellence published medical technology guidance recommending SI-BONE's iFuse® for the treatment of chronic sacroiliac joint pain.
Amedica Closes Sale of Spine Portfolio to CTL Medical
Amedica completed the sale of its spine business to CTL Medical, which is now exclusive owner of the metal and silicon nitride spine product portfolio.
Alphatec Gains FDA Clearance for OsseoScrew
Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw.
Renovis Surgical Receives FDA Clearance for Tesera X Lateral Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera® X Lateral Interbody Fusion system.
4WEB Partners with Tedan, Lattus on Total Lateral Solution
4WEB Medical entered into an exclusive partnership with Lattus Spine and TeDan Surgical Innovations to co-market a turnkey Total Lateral Solution, with retractor and implant.
NuVasive Enrolls Patients in Advanced Materials Science in XLIF Study
NuVasive commenced patient enrollment in a prospective, multicenter U.S. study evaluating advanced spinal implants used in XLIF® procedures.
SeaSpine Launches Regatta Lateral System
SeaSpine commenced full launch of the Regatta® minimally invasive lateral interbody fusion system.
Medtronic Launches Infinity OCT Spinal System
Medtronic commenced U.S. launch of the Infinity OCT system for posterior cervical fusion.
Nexxt Spine Clinical Trial Evaluating 3D Printed Ti vs. PEEK
Nexxt Spine commenced a clinical trial evaluating Nexxt Matrixx® 3D-printed lumbar interbody fusion devices vs. PEEK cages.
CoreLink Launches FLXfit15 Articulating Expandable Posterior Lumbar Interbody
CoreLink Surgical launched the FLXfit®15 articulating expandable intervertebral body fusion device.
SI-BONE Files for Proposed IPO
SI-BONE publicly filed for a proposed IPO, and applied to list on NASDAQ as SIBN. Proceeds will primarily support commercialization activities for the iFuse implant for treatment of SI joint dysfunction.
Providence Medical Technology Secures $25MM in Equity Financing
Providence Medical Technology closed US $25MM in new equity financing. Proceeds will support market expansion and clinical development of DTRAX® posterior cervical fusion instruments.
NICE Recommendation for TranS1 AxiaLIF in the UK
TranS1 announced NICE recommendation for approval of the AxiaLIF® system and presacral approach among standard arrangments to treat severe chronic low back pain.
SpineEx Files for $17MM IPO
SpineEx filed to raise up to US $17MM in an initial public offering to support commercialization of spinal devices, including an expandable cage for lateral lumbar fusion.
Meditech Spine Gains FDA Clearance for Cure Opel-C Plating System
Meditech Spine gained FDA 510(k) clearance to market the CURE Opel-C Plate implant system, an add-on technology to its CURE anterior cervical plate system and Talos-C HA interbody systems.
NuVasive Launches MAGEC X in UK
NuVasive commenced U.K. launch of MAGEC X, an extension of its MAGEC line to treat Early Onset Scoliosis.
Spine Wave Launches Paramount Anterior Cervical Cage
Spine Wave commenced full launch of the titanium Paramount® Anterior Cervical Cage for interbody fusion.
SpineVision Gains FDA Clearance, CE Mark for HEXANIUM TLIF Cage
SpineVision received FDA (510)k clearance and CE Mark approval for the 3D-printed HEXANIUM TLIF cage.
Captiva Spine Gains FDA Clearance for TowerLOX-EXT Tab Pedicle Screws
Captiva Spine announced FDA 510(k) clearance for the TowerLOX-EXT® MIS Extended Tab pedicle screw.
JNJ Acquires Emerging Implant Technologies
Johnson & Johnson Medical Devices is acquiring Emerging Implant Technologies, a manufacturer of 3D-printed titanium interbodies for spinal fusion.
Genesys Spine Gains FDA Clearance for AIS-C Interbody System
Genesys Spine announced FDA 510(k) clearance and launch of the AIS-C Stand-Alone interbody system for cervical spine.
NASS Conversations Reaffirm Spine’s Focus on Additive, Computer-Assisted, Materials
The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials and manufacturing.
Captiva Spine Gains FDA Clearance for TirboLOX-L Cage
Captiva Spine announced FDA 510(k) clearance and launch of the TirboLOX-L 3D-printed titanium lumbar cage.
4WEB Medical Reports 73% YOY Increase in Adoption of Lateral Spine Truss
4WEB Medical achieved a 73% YOY increase in surgeon adoption of its Lateral Spine Truss System.
NuVasive Launches TLX 20 Expandable Interbody
NuVasive commenced U.S. launch of the TLX® 20 Expandable interbody implant for use in lumbar procedures.
Eden Spine Gains FDA Clearance for SPHYNX Thoracolumbar Plate
Eden Spine received FDA 510(k) clearance to market the SPHYNX thoracolumbar locking plate.
Stryker Acquiring K2M
Stryker entered into a definitive merger agreement to acquire K2M for ~US $1.4BB in cash. The transaction is slated to close in 4Q18. For 2017, K2M posted revenue of $249.3MM, +8.8% vs. 2016.
SI-BONE Gains Exclusive Positive Coverage for iFuse in France
SI-BONE's iFuse® system for sacroiliac joint fusion will be added to the List of Refundable Products and Services in France, and has exclusive French National Healthcare System coverage.
Centinel Spine Completes Initial Cases Using FLX 3D Printed Titanium Interbodies
Centinel Spine completed initial cases with three different implant portfolios within its FLX platform of Integrated Interbody and non-integrated 3D-printed interbody fusion devices.
Nanovis Completes $5.5MM Funding Round
Nanovis completed a US $5.5MM funding round. Proceeds will support sales and distribution of FortiCore® interbody fusion devices.
Amedica Announces First Valeo C+CSC Procedure
Amedica marked completion of the first spinal fusion using the Valeo® C+CSC with Lumen interbody fusion device.
Osseus Fusion Gains FDA Clearance for 3D-Printed Lumbar IBFs
Osseus Fusion Systems received FDA 510(k) clearance to market Aries 3D-printed lumbar interbody fusion devices.
CoreLink Gains FDA Clearance for Foundation 3D ALIF
CoreLink received FDA 510(k) clearance to market the Foundation 3D Anterior Lumbar Interbody Fusion device.
Zavation Launches Facet, SI Screw Systems
Zavation commenced launch of its Facet screw and Sacroiliac screw systems.
Orthofix Reports 2Q18 Revenue
Alphatec 2Q18 Revenue
Fuse Medical Acquires Maxim Surgical
Fuse Medical acquired Maxim Surgical, a manufacturer of spinal fusion devices.
Globus Medical Reports 2Q18 Revenue
K2M Announces 2Q18 Revenue
NuVasive 2Q18 Revenue +8.5% vs. 2Q17
OrthoPediatrics Announces Expanded Indication for FIREFLY Pedicle Screw Navigation
OrthoPediatrics announced an additional FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide to include S2AI screw trajectory for sacral-iliac fixation in complex spinal reconstruction.
SeaSpine 2Q18 Revenue +7% vs. 2Q17
Zimmer Biomet Ortho Revenue +4% vs. 2Q17
CarboFix Gains FDA Clearance for Pedicle Screw
CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological patients.
Stryker Posts 2Q18 Revenue Growth of 8% YoY
ORTHOWORLD estimates Stryker's 2Q18 orthopaedic revenue at US $1,747.8MM, +8.0% from 2Q17, and 1H18 revenue at $3,472.6MM, +7.5% vs. 1H17. Trauma and Extremities Joint Recon remain high performers, with Interventional and Tritanium products contributing to strong spine segment growth.
DePuy Synthes Launches CONCORDE LIFT Expandable Interbody
DePuy Synthes commenced U.S. launch of the CONCORDE LIFT Expandable Interbody, part of the UNLEASH MIS TLIF Procedural Solution.
Implanet Opens Subsidiary in Germany
Implanet established a subsidiary in Germany, furthering its strategy to expand sales in the European market.
FBC Device Gains FDA Clearance for Interbody Implant
FBC Device received its first FDA 510(k) clearance, granted for the FBC 921 ALIF interbody implant.
ReVivo Medical Efficacy Study Results
Results from an efficacy study of ReVivo Medical's spinal fusion technology demonstrated that loadsharing through elastic micro-motion accelerates bone formation and interbody fusion.
HAPPE Spine Forms to Develop PEEK Interbody Implants
HAPPE Spine has formed to develop technology that supports construction of partial or fully porous hydroxyapatite-reinforced PEEK implants.
NuVasive Launches MAGEC X for Early Onset Scoliosis
NuVasive commenced U.S. launch of MAGEC X, an extension of its MAGEC line to treat Early Onset Scoliosis.
K2M Gains FDA Clearance, CE Mark Approval for CAYMAN United Plate
K2M received FDA 510(k) clearance and CE Mark approval for the CAYMAN® United Plate.
Vallum Gains FDA Clearance of Nanotextured PEEK Interbody
Vallum received FDA 510(k) clearance to market a PEEK interbody fusion device with a PEEKplus® nanotextured surface created with proprietary Accelerated Neutral Atom Beam technology.
NuVasive Launches Reline Low-Profile Modular Implants
NuVasive introduced the Reline® MAS® Midline® cortical pedicle screw system for posterior fixation.
Life Spine Launches CENTRIC-T Pedicle-Based Retractor
Life Spine commenced limited launch and announced first clinical use of the CENTRIC®-T Pedicle-Based Retractor for minimally invasive TLIF.
Cutting Edge Spine Gains FDA Clearance for EVOL ha-C Interbody
Cutting Edge Spine received FDA 510(k) clearance to market the EVOL ha-C cervical interbody system.
Medicrea Launches Australian Subsidiary
Medicrea entered into a joint venture with National Surgical to offer its products in Australia and New Zealand.
NuVasive Broadening Expandable Portfolio with Lateral Procedures
NuVasive is launching the XLIF® Lordotic Expandable interbody system for XLIF anterior column realignment, a minimally disruptive alternative to open procedures.
Life Spine’s Robotic Assisted Tools Used in ASC
Life Spine announced the first ASC procedures using robotic-assisted placement of CENTERLINE® Cortical Screws and PROLIFT® Expandable Spacers.
GS Medical Launches AnyPlus MIS Pedicle Screw System
GS Medical commenced U.S. launch of the AnyPlus® Extended Tab system for minimally invasive pedicle screw placement.
Renovis Surgical Gains FDA Clearance for New Tesera ALIF System
Renovis Surgical Technologies received FDA 510(k) clearance to market Tesera® SA Hyperlordotic ALIF, a standalone interbody fusion system.
Globus Medical Milestone: 3,000 Screws Implanted with ExcelsiusGPS
Globus Medical marked a milestone with successful implantation of >3,000 screws with ExcelsiusGPS® robotic guidance and navigation since late-2017 launch.
Tenon Medical Gains FDA Clearance for Catamaran Sacroiliac Joint Fixation
Tenon Medical received FDA 510(k) clearance to market the Catamaran Sacroiliac Joint Fixation system, indicated for sacroiliac joint fusion to treat joint disruptions and degenerative sacroilitis.
Study Validates NuVasive’s Porous PEEK Cohere
Study results indicate that NuVasive's porous PEEK technology, used in the Cohere® cervical interbody fusion device, presents a clinically viable option to improve osseointegration and fusion.
OrthoPediatrics Announces First RESPONSE Spine Procedure in Japan
OrthoPediatrics marked the first spine surgery in Japan with the RESPONSE spine system.
Globus Medical Launches CREO Cement Augmented Pedicle Screw
Globus Medical launched the CREO® Fenestrated Screw, designed for use with FORTRESS bone cement to treat thoracolumbar spinal tumors.
RTI Surgical Launches Fortilink-TS and -L Interbody Fusion Systems
RTI Surgical launched Fortilink®-TS and -L lumbar interbody fusion systems, which feature TETRAfuse® 3D printed polymer.
Safe Orthopaedics Enters Distribution Agreement with KiSCO for Japan
Safe Orthopaedics entered into an exclusive commercialization and distribution agreement in Japan with KiSCO.
Medacta Marks First US Surgery with MUST SI Joint Screw
Medacta announced the first surgery performed in the U.S. using the Medacta Unconstrained Screw Technology Sacro-Iliac Joint Screw (M.U.S.T. SI) for sacroiliac joint fusion.
Centinel Spine Gains FDA Clearance of FLX 3D Printed Titanium Interbodies
Centinel Spine received FDA 510(k) clearance to market the FLX platform of Integrated Interbody and non-integrated interbody fusion devices.
K2M Launches 100th Product
K2M achieved the milestone of its 100th product following FDA 510(k) clearance and launch of the OZARK Cervical Plate.
CoreLink Acquiring Expanding Orthopedics
CoreLink has acquired Expanding Orthopedics, developer of the FLXfit line of expanding interbody devices. Terms were not disclosed.
Implanet Opens UK Sales Branch
Implanet opened a branch in the U.K. to support expansion and growth in the adult degenerative spine market.
Spineology Rampart One Standard ALIF Interbody Gains Standalone FDA Clearance
Spineology received FDA 510(k) clearance to market the Rampart One Standard ALIF device without supplemental fixation.
Camber Spine Gains FDA Clearance for ENZA-A Titanium ALIF
Camber Spine received FDA 510(k) clearance to market the ENZA-A Titanium Anterior Lumbar Interbody Fusion system.
iOrthopedics Reports Patent Awards and Allowances
iOrthopedics has received patent awards and allowances for its Universally Expanding Cage, giving exclusive rights in the expandable interbody arena.
Medicrea Gains FDA Clearance for Patient-Specific Spinal Cage
Medicrea obtained what is reported to be the first FDA 510(k) clearance to market patient-specific spinal cages.
Safe Orthopaedics Acquires UK Distributor Qspine
Safe Orthopaedics will acquire the salesforce of U.K. distributor Qspine.
Medtronic Revenue Grows 3.7%
K2M Receives FDA Clearance for BACS Patient-Specific Module
K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices.
Medacta Launches Customizable MySpine MC Surgical Guides
Medacta announced FDA 510(k) clearance and launch of the MySpine Midline Cortical Pedicle Screw Placement Guide.
Implanet Launches JAZZ Evo® for Adult Degenerative Spine Disease
Implanet launched JAZZ Evo® for adult vertebral fusion. The device is the first in a new range of JAZZ® connectors.
Life Spine Gains FDA Clearance for PRO-LINK Ti Stand-Alone Cervical Spacer
Life Spine received FDA 510(k) clearance to market additional indications for the PRO-LINK® Ti Stand-Alone Cervical Spacer.
Wenzel Spine Announces Case Study of VariLift-LX System
Wenzel Spine announced publication of a case series detailing endoscopic transforaminal decompression and fusion with the VariLift-LX system.
Zimmer Biomet Gains 510(k) Clearance for Zyston Strut Open Titanium Interbody Spacer
Zimmer Biomet received FDA 510(k) clearance to market the Zyston® Strut Open Titanium Interbody Spacer, the company's first 3D-printed titanium spinal implant.
Cerapedics Study Results: i-FACTOR Bone Graft in Lumbar Posterolateral Spine
Study results indicate that Cerapedics' i-FACTOR Peptide Enhanced Bone Graft demonstrated a 50% fusion rate in lumbar posterolateral spine surgery patients vs. 20% fusion rate with allograft.
Providence Medical Technology Gains FDA Clearance for DTRAX Spinal System
Providence Medical Technology announced FDA 510(k) clearance to market its DTRAX® system for use in posterior cervical fusion.
Xtant Medical Expands Cervical Portfolio with First Porous Titanium Implant
Xtant Medical received FDA 510(k) clearance for its InTice-C Porous Titanium Cervical Interbody System.
Globus Medical Announces Positive LLIF Study Results
In a study comparing expandable and static LLIF devices, at 2-year follow-up, researchers observed no implant subsidence in patients treated with expandable devices, with 16% subsidence in levels treated with static spacers.
K2M Launches MOJAVE PL 3D Expandable Interbody
K2M commenced full U.S. commercial launch of the MOJAVE PL 3D Expandable Interbody featuring Lamellar 3D Titanium Technology.
Alphatec Announces 1Q18 Revenue
Xtant Medical Posts 1Q18 Revenue
Globus Medical Posts 1Q18 Revenue
K2M Reports 1Q18 Revenue
NuVasive Posts 1Q18 Revenue
UHC’s Bundled Payments Demonstrate Improved Outcomes, Reduced Costs
UnitedHealthcare's Spine and Joint Solution bundled payment program has demonstrated fewer readmissions and complications following surgery and generated ~$18MM in savings for participating employers.
SeaSpine 1Q18 Revenue Grows 4% YoY
Medtronic Launches Advanced SynergyTLIF Workflow for Lumbar Spine Surgery
Medtronic introduced the SynergyTLIFSM workflow to perform a completely navigated MIS spinal procedure in fewer intra-op steps.
Medtronic Launches TiONIC 3D Printed Titanium for Spine Implants
Medtronic launched TiONIC 3D-printed titanium technology for spinal implants.
ChoiceSpine Launches Tiger Shark Porous Interbody Device
ChoiceSpine launched Tiger Shark, a next-gen titanium alloy interbody created with BioBond proprietary porous surface structure.
Meditech Spine Gains Additional FDA Clearance for CURE Lumbar Plate
Meditech Spine received FDA 510(k) clearance for CURE Lumbar Plating iView and QMax, with new sizing options to complement the company's existing CURE system.
Medtronic Gains FDA Approval for INFUSE with Additional PEEK Implants
Medtronic gained FDA approval for use of Infuse bone graft with additional PEEK-based implants in oblique lateral and anterior lumbar interbody fusion procedures at one level.
DePuy Synthes Launches PROTI 360 Interbody Devices
DePuy Synthes commenced U.S. launch of PROTI 360°, interbody fusion systems featuring titanium-integrated PEEK with 360 degrees of titanium integration.
Spineart Achieves Milestone 1,000 Procedures with Juliet Ti-LIFE
Spineart has completed >1,000 procedures in the U.S. utilizing JULIET Ti-LIFE titanium technology.
PediGuard Used in 1st Deformity Surgery in China
SpineGuard announced the first spinal deformity procedure to be performed in China using the PediGuard® device for pedicle screw placement.
Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI
Patrick Sweeney, M.D., is a spine surgeon with a special interest in minimally invasive surgery. He is also Founder and Medical Director of the Center for Minimally Invasive Surgery, an ASC, as well as an inventor/entrepreneur, and founder of a device company and an eHealth entity. We spoke with him about his diverse orthopaedic endeavors.
iOrthopedics Files Additional US Patent Application
iOrthopedics filed another U.S. patent application on the Universally Expanding Cage, protecting its novel design that supports customized reconstructive spinal surgery.
Safe Orthopaedics Reaches Milestone 10,000th Surgical Kit Sale
Safe Orthopaedics marked the sale of >10,000 sterile kits for vertebral surgery worldwide, since launch.
Spineology U.S. Fusion Trial Interim 12-Month Outcomes Data
Initial outcomes from the SCOUT trial of Spineology's OptiMesh® device revealed statistically significant improvements in low back pain and function scores at 6 and 12 months.
Life Spine Posts 1Q18 ProLift Revenue +93% vs. 1Q17
CoreLink’s Full Launch of Foundation 3D-Printed Interbody Cages
CoreLink commenced full commercial release of Foundation 3D interbody cage systems for cervical and lumbar fusion.
iOrthopedics Awarded IP Validation
iOrthopedics was awarded U.S. Patent No. 9,861,494 for a Universally Expanding Spine cage.
Globus Launches ELSA Expandable Lateral Spacers
Globus Medical launched ELSA® AL and ELSA®-ATP lateral expandable interbody spacers with integrated screw fixation.
CTL Gains FDA Approval for Seurat Pedicle Screw
CTL Medical gained FDA 510(k) clearance to market the SEURAT Universal Pedicle Screw. The product is slated for 2H18 launch.
NuVasive Launches ALIF Retractor for Lateral and Supine Surgery
NuVasive launched ALIF Access, its first Maximum Access Surgery ALIF retractor for lateral and supine surgery approaches.
First Implant of Spinal Resources Swedge Pedicle Screw
Spinal Resources announced successful clinical implantation of the first Swedge Pedicle Screw.
NuVasive Porous PEEK Material Impaction Study Results
Studies demonstrated advantages of NuVasive's Porous PEEK interbody fusion devices vs. titanium-coated PEEK in impaction durability.
Nanovis Gains FDA Clearance of FortiCore Interbodies with Nanosurface Technology
Nanovis received FDA 510(k) clearance to market FortiCore® interbody fusion devices that feature a Nanosurface-enhanced porous titanium scaffold, intermolded with a PEEK core.
RTI’s Simmetry Reduces SI Joint Range of Motion
Study results demonstrate that RTI Surgical's Simmetry® Sacroiliac Joint Fusion system provided effective joint fixation, markedly reducing range of motion in the SI joint.
Life Spine Gains FDA Clearance of PLATEAU-LO Insert and Rotate Spacer
Life Spine received FDA 510(k) clearance to market the PLATEAU®-LO Insert and Rotate Spacer system for lumbar interbody fusion.
K2M Launches Next-Gen YUKON OCT System
K2M commenced full launch of the next-generation YUKON OCT posterior fixation system, designed to support cervical sagittal balance in the occipito-cervico-thoracic regions.
CTL Medical Gains FDA Clearance for MATISSE Ti-PEEK ACIF Cage
CTL Medical received FDA 510(k) clearance for the MATISSE Ti-PEEK ACIF cage, featuring TiCro surface technology.
Alphatec Reports 4Q17, 2017 Revenue
Benvenue Medical Luna Interbody Fusion Study Results
Retrospective analysis of Benvenue Medical's Luna® 3D Multi-Expandable Interbody Fusion system indicate that minimally invasive TLIF placement of the device was safe and effective.
Captiva Spine Launches TransFasten SI Fusion and HyperLOX Posterior Cervical System
Captiva Spine announced initial TransFasten Posterior SI Fusion procedures, and launch of the HyperLOX posterior cervical system.
Life Spine Announces First Clinical Use of SENTRY 2 Lateral Plate
Life Spine announced the first clinical use of the SENTRY 2 lateral plate.
Amedica Receives FDA Clearance of Valeo C+CsC
Amedica announced FDA 510(k) clearance of the Valeo C+CsC with Lumen interbody fusion device.
Stryker Gains FDA Clearance for Tritanium TL Curved Posterior Lumbar Cage
Stryker Spine received FDA 510(k) clearance to market Tritanium® TL, a 3D-printed curved posterior lumbar interbody fusion cage. The device will launch in 2Q18.
WishBone Medical to Distribute Implanet’s JAZZ Implants
WishBone Medical entered into a U.S. distribution agreement with Implanet addressing JAZZ spinal implants.
Orthofix Cervical-Stim Device Shown to Improve Fusion Rates
Studies show that use of pulsed electromagnetic field treatment after ACDF significantly increased the fusion rate vs. control at 6 and 12 months, for participants at risk for pseudoarthrosis.
Spineology Receives USPTO Notice for Duo LIF Implant
Spineology received a Notice of Allowance from the USPTO that includes three independent device claims covering the Duo intervertebral implant
SeaSpine Announces 4Q17, 2017 Revenue
NuVasive Posts 4Q17, 2017 Revenue
Implanet and L&K Biomed Finalize Cross-Distribution Agreements
Implanet and L&K Biomed finalized agreements for cross-distribution of spinal products in the U.S., Asia/Oceania and Europe.
Globus Medical Posts 4Q17 and 2017 Revenue
Medtronic Posts FY3Q18 Revenue Growth
Spine Wave Launches Proficient Posterior Cervical Spine Implants
Spine Wave expanded the Proficient® Posterior Cervical Spine system to address complex posterior cervical/thoracic procedures.
Nexxt Spine Milestone: 250 Implantations of NEXXT MATRIXX Interbodies
Nexxt Spine marked the milestone of 250 implantations of its NEXXT MATRIXX® interbody devices.
Spineology Completes Enrollment in Trial of OptiMesh Spinal Fusion Implant
Spineology completed enrollment in the Spineology Clinical Outcomes Trial, investigating use of the OptiMesh® implant in instrumented lumbar interbody fusion.
TranS1 Granted Three New Patents
TranS1 was granted patents addressing presacral interbody fusion technologies, including new expandable cages and a new sacroiliac fusion technique.
Camber Spine Notes First Procedures with SPIRA-C Open Matrix Interbody
Camber Spine announced successful completion of initial surgeries with the SPIRA-C Open Matrix cervical interbody fusion implant.
Emerging Implant Technology Gains FDA Approval for Multilevel Cervical Cage
Emerging Implant Technologies gained expanded FDA clearance to market EIT Cellular Titanium® Cervical Cages for multiple contiguous levels.
Orthofix Gains FDA Clearance for FORZA XP Expandable Spacer
Orthofix received FDA 510(k) clearance to market the FORZA® XP Expandable Spacer for posterior and transforaminal lumbar interbody fusion.
SeaSpine Expands Ventura NanoMetalene Range
SeaSpine expanded the Ventura NanoMetalene® interbody line to include sizes that accommodate a larger range of posterior procedures and more patient anatomies.
Implanet Enters Distribution Agreement with Aegis Spine
Implanet entered into a U.S. distribution agreement with Aegis Spine, subsidiary of L&K Biomed, to complement Implanet's commercialization activity in the region.
Amedica Provides a Business Update
Among its business updates, Amedica announced that the Taurus Pedicle Screw generated ~US $1.3MM in 2017 revenue and was employed in >250 procedures since its 1Q17 launch.
Spine Wave Launches GraftMag Graft Delivery System
Spine Wave launched the GraftMag® bone graft delivery system for thoracolumbar spinal fusion procedures.
Life Spine ProLift Spacer Revenue +493% vs. 2016
4WEB Medical Posts 57% YoY Revenue Growth
Spineology Duo LIF Postmarket Study Update
First study cases are complete in Spineology's postmarket investigation of the Duo Lumbar Interbody Fusion system.
K2M Reports Preliminary 4Q17 and 2017 Revenue
RTI Surgical Acquiring Zyga Technology
RTI Surgical entered into an agreement to acquire Zyga Technology, developer of the SImmetry® Sacroiliac Joint Fusion system.
Zyga Reports Initial Results in SImmetry SI Fusion Study
Initial outcomes from Zyga's EVSI study indicate a significant reduction in low back pain and opioid use in patients receiving the SImmetry® SI Joint Fusion implant.
NuVasive Update on COALESCE, COHERE Interbody Fusion Devices
NuVasive launched COALESCE for Thoracolumbar Interbody Fusion, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion device with expanded indications.
Life Spine Announces Initial Cases with SIMPACT Tri-Fin Sacroiliac Joint Fusion
Initial cases are complete and multiple surgeries performed with Life Spine's SIMPACT™ Tri-Fin Sacroiliac Joint Fusion device, following its November 2017 launch.
K2M Receives CE Mark for CAPRI Cervical 3D Expandable Cage
K2M received approval under the CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage, and announced completion of its first surgical case.
Camber Spine Gains FDA Clearance for Spira-C Open Matrix Cervical Interbody
Camber Spine received FDA 510(k) clearance to market the SPIRA™-C Open Matrix cervical interbody fusion device.
Globus Medical SECURE-C Disc vs. ACDF: 7-Year Follow-up
Results of seven-year clinical trial follow-up indicate superiority of Globus Medical's SECURE-C® cervical disc vs. ACDF in the treatment of cervical disc disease.
First US Procedures for Emerging Implant Technologies Spinal Cages
Emerging Implant Technologies announced completion of first U.S. procedures with its 3D-printed titanium spinal cages.
Xtant Medical Reports 3Q17 Revenue
Medicrea Gains FDA Clearance for 3D-Printed Ti Interbody
Medicrea received FDA 510(k) clearance to market IB3D™ 3D-printed interbody devices, and introduced its AdapTEK™ in-house additive manufacturing technology.
Life Spine Launches SIMPACT TRI-FIN Sacroiliac Joint Fixation Screws
Life Spine commenced limited launch of the SIMPACT™ TRI-FIN sacroiliac joint fixation screw.
Titan Spine’s First Endoskeleton Interbody Fusion Cases in Australia
Titan Spine entered the Australian market with its Endoskeleton® interbody fusion devices and surface technology.
Globus Medical Announces 3Q17 Revenue
Alphatec Spine Posts 3Q17 Revenue
SpineGuard and XinRong Medical Launch PediGuard in China
SpineGuard and XinRong Medical are launching Classic PediGuard® pedicle screw placement tools in China.
SeaSpine Reports 3Q17 Revenue
Amedica Submits FDA 510(k) for Valeo Implant with Lumen
Amedica made a (510)k submission to FDA for its Valeo C+CSC with Lumen cervical spinal implant.
K2M 3Q17 Revenue Growth Up 6% YoY
Zimmer Biomet 3Q17 Orthopaedic Revenue
Pinnacle Spine Files to Market InFill with HA-Enhanced PEEK OPTIMA
Pinnacle Spine expects 4Q17 FDA 510(k) clearance to market InFill® Lateral Lumbar Fusion systems with Invibio's HA Enhanced PEEK-OPTIMA material.
Orthofix 3Q17 Revenue +7% Year Over Year
Stryker’s 3Q17 Orthopaedic Revenue +4% vs. 3Q16
SAGICO Launches Spinal Restoration Technologies
SAGICO commenced North American debut of its expandable interbody fusion system, comprising Aria Lumbar and Arion Cervical devices.
NuVasive 3Q17 Revenue +3.2% vs. 3Q16
Study Indicates Reduced Subsidence with 4WEB’s Lateral Spine Truss
Studies indicate that 4WEB Medical's Lateral Spine Truss demonstrated a better resistance to subsidence vs. an annular interbody implant.
CoorsTek Medical Marks First Human Implantation of New SI Fusion System
CoorsTek Medical announced the first human implantation of Integrity-SI™ Fusion MIS implants, developed in collaboration with the Mayo Clinic.
Initial Surgeries with Expanding Orthopedics’ FLXfit 15 Cage
Expanding Orthopedics announced first surgeries with FLXfit™15, its 3D-expandable cage.
RTI Surgical Launches 3D-Printed Polymer Interbody: Fortilink-C
RTI Surgical launched its first device featuring TETRAfuse® 3D-printed polymer material: the Fortilink®-C IBF system.
Zimmer Biomet Launches Vitality+ and Vital Spinal Fixation in the U.S.
Zimmer Biomet commenced U.S. launch of Vitality®+ and Vital™ spine fixation lines.
GS Solutions Launches AnyPlus DLIF System
GS Medical USA commenced full launch of AnyPlus® for Direct Lateral Interbody Fusion, as well as Anterior and Posterior Disc Prep sets.
DePuy Synthes Launches MIS Spine Surgical Tools
DePuy Synthes launched VIPER PRIME™ and CONCORDE® Clear MIS Discectomy tools for MIS spinal fusion.
ChoiceSpine Receives FDA Clearance for Blackhawk Interbody Fusion Device
ChoiceSpine received FDA 510(k) clearance to market Blackhawk™, an integrated, self-locking anterior cervical fusion device.
Sites Medical and Integrity Implants Enter License Agreement
Sites Medical entered into an agreement to license OsteoSync™ Ti technology to Integrity Implants for its use in expandable interbody devices.
Stryker Launching Serrato Pedicle Screw, Tritanium Cervical Cage
Stryker is fully launching its Serrato™ pedicle screw and Tritanium® C Anterior Cervical Cage devices.
Completion of Initial Spinal Jaxx Surgeries
NeuroPro Spinal Jaxx announced completion of the first commercial surgeries with the Spinal Jaxx expandable lumbar interbody fusion device.
VGI Medical Enters Lateral Spine Market
VGI Medical commenced commercial launch of the VerteLP® Lateral Interbody Fusion system.
K2M Acquires Cervical VBR from Cardinal Spine
K2M acquired Cardinal Spine's cervical static corpectomy cage, to be branded as the PALO ALTO® system.
RTI Surgical Introduces TETRAfuse 3D-Printed Interbody Polymer Material
RTI Surgical introduced TETRAfuse®, reportedly the first 3D-printed polymer implant material to demonstrate trabecular bone ingrowth plus radiolucency and bone-like mechanical properties.
NuVasive Launches New Lateral Procedural Technologies
NuVasive launched Lateral ALIF, XLIF Crestline™ and Lateral MAS® Fixation, expanding its lateral single-position procedure portfolio.
DePuy Synthes 3Q17 Orthopaedic Revenue +0.5% YoY
Spineology Initiates Postmarket Study of Duo Lumbar Interbody Fusion System
Spineology launched a postmarket study to assess patient outcomes with the Duo™ Lumbar Interbody Fusion system.
NuVasive Launches 3D-Printed Modulus XLIF Titanium Implants
NuVasive launched Modulus® XLIF®, 3D-printed titanium implants for use in lateral lumbar interbody fusion.
Implanet Gains CE Mark Approval for JAZZ Passer
Implanet received approval under the CE Mark to market the JAZZ® Passer, used in posterior fixation procedures.
Life Spine Introduces the SENTRY ALIF Plate
Life Spine commenced alpha launch of the SENTRY™ ALIF Plating System, designed to omit the need for posterior stabilization with anterior lumbar interbody fusion.
DePuy Synthes Debuts VIPER PRIME MIS Pedicle Screw
DePuy Synthes unveiled the VIPER PRIME™ pedicle screw. Full EMEA commercial launch is slated for early 2018.
NuVasive Receives Expanded FDA 510(k) Clearance for TLX Interbody System
NuVasive received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 20° cage, use with allogeneic bone graft and use in additional levels of the spine.
4WEB Medical Launches Next-Gen Anterior Spine Truss
4WEB Medical launched its next-generation 3D-printed Anterior Spine Truss interbody fusion system.
Nexxt Spine Gains FDA Clearance for NEXXT MATRIXX Devices
Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices.
Zimmer Biomet Launches Avenue T TLIF Cage with VerteBRIDGE Plating
Zimmer Biomet commenced U.S. launch of the Avenue® T TLIF Cage, featuring self-guided, curved VerteBRIDGE® plating.
Spineology Fully Launches Elite Expandable Interbody Fusion System
Spineology commenced full market release of the Elite™ Expandable Interbody Fusion system. More than 300 cases have been completed since limited launch in 2Q16.
K2M Receives FDA Clearance for YUKON OCT System
K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine.
Wenzel Spine Updates VariLift-C Interbody System
Wenzel Spine commenced U.S. launch of revisions to its VariLift®-C standalone interbody fusion system, including new implant sizes and MIS instrumentation.
Expanding Orthopedics’ FDA Clearance for FLXfit15 3D-Articulated Expandable Cage
Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 expandable interbody cage.
Providence Medical Receives FDA Clearance for ALLY Posterior Fixation
Providence Medical Technology received FDA 510(k) clearance to market the ALLY™ Posterior Fixation system as an adjunct to fusion in the cervical spine.
HD LifeSciences Launches NanoHive Lumbar Interbodies
HD LifeSciences received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.
SeaSpine Launches Shoreline Anterior Cervical Standalone System
SeaSpine commenced full commercial launch of Shoreline®, its anterior cervical standalone system.
Spine Companies $100MM to $2BB: Strategic Activity Update
Highmark Now Covers Zyga SI Fusion System
U.S. insurer Highmark now covers all U.S. FDA-cleared instrumentation for SI joint fusion, including cages or screws, with or without bone graft.
Interim Results in ALLOB Phase IIA Spinal Fusion Study
Interim results in a Phase IIA trial with Bone Therapeutics' ALLOB® show evidence of successful spinal fusion and statistically significant improvements at 12 months.
Xtant Medical Receives FDA Clearance for Expanded Indications of Irix-A
Xtant Medical received FDA 510(k) clearance to market line extensions for the Irix-A standalone interbody spacer.
Implanet Gains FDA Clearance for JAZZ Passer
IMPLANET received FDA 510(k) clearance to market JAZZ™ Passer, a system of spinal instruments and braided band technology.
Spinal Resources’ FDA Clearance of Swedge Pedicle Screw
Spinal Resources received FDA 510(k) clearance to market the Swedge™ Pedicle Screw system.
Medtronic Posts FY1Q18 Revenue Growth
ChoiceSpine Completes 1,000th TOMCAT ACDF
ChoiceSpine completed its 1,000th TOMCAT anterior cervical discectomy and fusion procedure.
EIT Emerging Implant Technologies Acquires 22 Patents for 3D Printed Expandable Cage Technology
Emerging Implant Technologies acquired a portfolio of 22 issued and pending patents covering 3D printed expandable spinal fusion cages.
CoreLink Launches Stackable Guide Wire for Entasis SI Joint Fusion
CoreLink introduced Scaltoff™, a stackable guide wire for the Entasis® Sacroiliac Joint Fusion system.
Life Spine Performs Cases with Multiple Methods of In Situ Expansion
Life Spine announced the first cases performed using multiple methods of in situ expansion with the PROLIFT® Lordotic system and the TiBOW™ Expandable TLIF Spacer.
Stryker Spine Receives FDA 510(k) Clearance for Serrato Pedicle Screw
Stryker Spine received FDA 510(k) clearance to market the Serrato™ Pedicle Screw.
Spine Wave Launches Proficient Posterior Cervical System
Spine Wave commenced limited market release of the Proficient® Posterior Cervical system. Full launch is slated for early 4Q17.
Camber Spine Commences U.S. Launch of SPIRA Open Matrix ALIF
Camber Spine Technologies received FDA 510(k) clearance and commenced U.S. launch of the SPIRA™ Open Matrix ALIF device, manufactured with additive techniques.
Expanding Orthopedics Receives Additional Patents for Interbody Cage Technology
Expanding Orthopedics was granted two additional U.S. Patents covering expandable interbody cage technology.
Renovis Receives FDA Clearance for 3D-Printed PLIF Systems
Renovis Surgical received FDA 510(k) clearance to market Tesera® 3D-printed posterior lumbar interbody fusion systems.
Life Spine’s First Clinical Use of TiBOW MIS TLIF Expandable Spacer
Life Spine announced the first clinical uses of TiBOW™, its minimally invasive expandable TLIF system featuring Osseo-Loc™ surface technology.
K2M 2Q17 Revenue
K2M Acquires Expandable Interbody IP Portfolio
K2M acquired exclusive license to a portfolio of 17 issued and pending patents for expandable interbody technology.
Globus Medical Reports 2Q17 Revenue
SI-BONE Maintains Exclusive Positive Coverage with Blue Cross and Blue Shield
Blue Cross and Blue Shield has updated its coverage policy for MIS SI joint fusion in various states, and maintained an exclusive positive coverage for SI-BONE's iFuse Implant.
Titan Spine Doubles nanoLOCK Surgeon Users
Stryker Reports 2Q17 Revenue
Medicrea Announces First MIS Spine Surgery with Patient-Specific Implants
Medicrea announced completion of the world's first minimally invasive spine procedure using patient-specific implants, with the UNiD™ MIS Rod.
First US Surgeries with 4WEB 3D-Printed Lateral Spine Truss
4WEB Medical announced first surgeries with its Lateral Spine Truss interbody fusion device.
Camber Spine Exceeds 150th Implantation of ENZA Zero-Profile ALIF
Camber Spine Technologies has surpassed 150 implantations of its ENZA™ Zero-Profile ALIF device at one year following launch.
CTL Medical Receives FDA 510(k) Clearance for MATISSE ACIF Cage
CTL Medical received FDA 510(k) clearance to market the MATISSE™ titanium ACIF cage.
Australia Regulatory Approval for Providence Medical’s DTRAX Cervical Fusion Devices
Providence Medical Technology was granted regulatory approval in Australia for DTRAX® cervical fusion devices.
Vertera Spine Receives FDA 510(k) for COALESCE PEEK LIF Device
Vertera Spine received FDA 510(k) clearance to market the COALESCE™ interbody fusion device for ALIF, TLIF, PLIF and LLIF procedures.
Trauma and Spine Markets Gain New FDA Clearances
In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies entering the U.S. market.
DePuy Synthes 2Q17 Orthopaedic Revenue
Premia Spine Launches IDE Study of TOPS Spinal Arthroplasty Device
Premia Spine launched its U.S. pivotal Investigational Device Exemption study of the TOPS™ posterior arthroplasty device vs. traditional lumbar fusion.
Emerging Implant Technologies Receives FDA Clearance for Interbody Devices
Emerging Implant Technologies received FDA 510(k) clearance for 3D-printed spinal interbody devices to address ALIF, PLIF, TLIF and cervical procedures.
Study Results: Inspired Spine’s OLLIF Procedure for Adult Scoliosis
Research indicates that Inspired Spine's OLLIF procedure yielded substantial pain relief and minimal post-op complications in the trestment of adult degenerative scoliosis.
Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices
Strategic orthopaedic-related 510(k)s issued in June 2017 include: Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS); Tranquil Interbody System (Nexus Spine); PHA S1 Spinal System (Phamedica); Total Hip Arthroplasty Device (Responsive Orthopedics/Medtronic); Interbody Fusion System (Spinal Analytics & Geometrical Implant); Channel Cervical Interbody System (Summit Spine); Coalesce Lumbar Interbody Fusion System (Vertera Spine)
SeaSpine Introduces Skipjack Expandable Interbody System
SeaSpine commenced limited launch and announced initial case completion for the Skipjack™ Expandable Interbody System.
K2M Enters Distribution Agreement with Japan Medicalnext
K2M signed a long-term exclusive distribution agreement with Japan Medicalnext.
Xenco Medical Expands ASC CerviKit in the US
Xenco Medical expanded U.S. availability of the ASC CerviKit delivery and storage platform for disposable ACDF systems.
Study Results: Providence Medical’s CAVUX and DTRAX Fusion Technologies
Studies indicate that Providence Medical Technology's tissue-sparing cervical fusion devices, CAVUX® Cervical and DTRAX® Expandable cages, yielded improvements in pain, with radiographic confirmation of fusion.
Full Commercial Launch for SeaSpine’s Mariner Posterior Fixation
SeaSpine commenced full launch of the Mariner® pedicle-based system for posterior spinal fixation.
Regulatory Clearances for K2M’s NILE Proximal Fixation System
K2M received FDA 510(k) clearance and approval under the CE Mark for the NILE® Proximal Fixation system to treat complex spinal deformity.
Life Spine Expands OSSEO-LOC Spinal Implant Portfolio
Life Spine commenced full commercial launch of new OSSEO-LOC™ titanium surface-treated spinal implants, such as ProLift® Expandable PLIF/TLIF and TiBOW™ Expandable TLIF spacers.
Meditech Spine Releases CURE LP System and Talos Spacers in Pre-Packaged Tray
Meditech Spine received FDA 510(k) clearance for its CURE Lumbar Plating System, expected to be packaged as comprehensive solution with Talos.
Spine Wave Enters ALIF Market with Leva AF Commercial Launch
Spine Wave launched Leva® AF, a titanium device for anterior lumbar interbody fusion.
Intellirod Spine Acquires New Financing and IP
Intellirod Spine raised additional equity financing from new and existing investors to support the commercialization of sensor technologies and related lumbar fusion implants.
Spineology Receives FDA Clearance for Rampart One Anterior Lumbar Interbody Fusion System
Spineology enters anterior market with FDA cleared Rampart One Interbody Fusion System.
K2M Launches MOJAVE 3D-Printed Expandable Posterior Lumbar Interbody
K2M announced FDA 510(k) clearance of MOJAVE™ PL, a 3D-printed expandable posterior lumbar interbody system featuring Lamellar 3D Titanium™.
Implanet Launches JAZZ Braid in Europe and U.S.
Implanet launched the JAZZ™ Braid device in the EU and U.S. following regulatory clearance in those regions.
Zyga Receives New Patent Allowances for SImmetry Sacroiliac Joint Fusion System
Zyga Technology announced the issuance of U.S. Patent No. 9,662,124, relating to the design of the SImmetry Decorticator®.
K2M Introduces SAHARA AL Expandable Stabilization
K2M introduced SAHARA™ AL, the company's first expandable interbody product.
Meditech Spine Receives FDA Clearance for Talos Lumbar PEEK Devices
Meditech Spine received FDA 510(k) clearance for Talos® Lumbar PEEK IBF devices enhanced with hydroxyapatite.
Medicrea Announces FDA Clearance of PASS TULIP Top-Loading Spinal Fixation
Medicrea received FDA 510(k) clearance and performed first surgeries with PASS® TULIP top-loading fixation.
SI-BONE Receives FDA Clearance for iFuse-3D
SI-BONE received FDA 510(k) clearance and commenced full U.S. launch of the iFuse-3D™ Implant.
Vertera Spine Receives CMS ICD-10 Code for COHERE Cervical Interbody Fusion Device
CMS issued a new ICD-10 code for a radiolucent porous interbody fusion device, supporting Vertera Spine's COHERE cervical device.
Polyaxial ZIP ISP Technology Available for Out-Licensing
Aurora Spine's proprietary implant locking technology is available for out-licensing or private labeling opportunities.
Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators
Zimmer Biomet is recalling SpF® PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to potential cytotoxicity issues that were found during routine monitoring.
K2M Launches MESA 2 Cricket Instrumentation
K2M launched MESA 2 Cricket™ instrumentation, an enhancement to the MESA® 2 pedicle screw system.
Medtronic Reports FY4Q17 Revenue
Life Spine Fully Launches PROLIFT Lordotic Expandable Interbody System
Life Spine commenced full commercial launch of the PROLIFT® Lordotic expandable interbody system with OSSEO-LOC™ surface treatment.
Xtant Medical 1Q17 Revenue
Vertebral Technologies Granted Patent for Modular Device Design
Vertebral Technologies received notice of allowance for its patent, "Methods and Apparatus for Minimally Invasive Modular Interbody Fusion Devices."
Providence Medical Technology Secures New $10.5MM Financing
Life Spine’s 510(k) Clearance of CRANIAL FUSION System with SOLSTICE Screws
Life Spine received FDA 510(k) clearance of its CRANIAL FUSION system, expanding indications for use of SOLSTICE Polyaxial Screws into the cervical spine.
SeaSpine Posts 1Q17 Revenue
Inspired Spine Presents OLLIF Procedure Study Results
Results from a 124-patient study indicate that Inspired Spine's OLLIF procedure was completed at ~2x the speed of an open TLIF, and reduced blood loss by >80% vs. TLIF.
iFuse SI Fusion Implant Covered by TRICARE
TRICARE, a managed healthcare program for active duty and retired members of the U.S. military, established a written coverage policy for minimally invasive SI joint fusion such as is provided with SI-BONE's iFuse™ implant.
Premia Spine Secures FDA Approval for IDE Study of TOPS
Premia Spine secured FDA approval for a pivotal IDE study of TOPS™, a posterior arthroplasty device for the treatment of spondylolisthesis and spinal stenosis. The study seeks to establish the superiority of TOPS vs. traditional lumbar spinal fusion.
Medikon to Distribute InterFuse in Turkey
Vertebral Technologies partnered with Medikon for distribution of InterFuse® spinal fusion products in Turkey.
Globus Medical Reports 1Q17 Revenue
Medtronic to Update Labeling for NavLock Tracker
Medtronic issued a Safety Notice related to use of non-Medtronic instruments with the NavLock™ Tracker, an accessory to its StealthStation Surgical Navigation system.
Implanet Receives CE Mark Approval for JAZZ Standalone Implant
Implanet received approval under the CE Mark for the JAZZ™ Standalone implant for posterior spinal fixation.
K2M Posts 1Q17 Revenue, Announces Product Approvals in Japan
K2M posted 1Q17 revenue of US $61.9MM, +9.9% vs. 1Q16. (U.S. $46.2MM, +9.5%; ex-U.S. $15.7MM, +11.1%) Following 1Q, the company received key product registrations from Japan's Pharmaceuticals and Medical Devices Agency, and can now implement a new distribution strategy in that region.
Innovasis Receives FDA 510(k) for Ax Standalone ALIF System
Innovasis received FDA 510(k) clearance to market Ax™, a standalone system for anterior lumbar interbody fusion.
NuVasive Reports 1Q17 Revenue Growth of +16.2% vs. 1Q16
Amedica: Regulatory Clearance for Valeo in Australia
Amedica has been granted marketing clearance in Australia for Valeo® interbody fusion devices.
SI-BONE 6-year Clinical Results of iFuse Implant System
Six-year study results on the treatment of SI joint disorders indicated that treatment with conservative management or radiofrequency denervation led to worsened outcomes, while iFuse Implant patients demonstrated superior improvements.
Amendia Acquired Spinal Elements
Amendia acquired Spinal Elements, provider of implants, instruments and orthobiologics. Terms were not disclosed.
Zyga EVoluSIon Study Enrolls 100th Patient
Zyga Technology enrolled the 100th patient in the EVoluSIon trial investigating long-term results and pain reduction following the SImmetry® Sacroiliac Joint Fusion procedure.
United Orthopedic Acquires A-Spine, Expanding Sales in China
United Orthopedic acquired A-Spine Asia, developer of spinal fixation, osteoplasty and vertebral body replacement systems, for US $20.0MM. For 2016, A-Spine posted revenue of $11.3MM.
24-month CT Fusion and Clinical Results for SImmetry SI Joint Fusion
Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion indicate radiographically-evident fusion as early as 12 months, and increased fusion rates at 24 months.
Safe Orthopaedics Expands Product Availability in Paris
Safe Orthopaedics' products for thoracolumbar spinal fusion have been listed for availability to ~1/4 of the France market.
Inspired Spine Reaches 500 OLLIF Procedure Milestone
Inspired Spine reached the milestone of 500 Oblique Lateral Lumbar Interbody Fusion procedures completed.
Aurora Spine Issued U.S. Patent for Polyaxial ZIP
Aurora Spine was issued U.S. Patent No. 9,603,637, "Polyaxial Interspinous Fusion Implant and Bone Growth Stimulation System."
K2M and LifeHealthcare Distribution Agreement
K2M and LifeHealthcare entered into a new 5-year distribution agreement for K2M's spinal technologies in Australia and New Zealand.
Alphatec Spine Launches Battalion Lateral System with Squadron Retractor
Alphatec Spine launched and completed initial procedures with the Battalion™ Lateral System and Squadron™ Lateral Retractor.
NICE Recommendation for MIS SI Joint Fusion Surgery
The U.K.'s National Institute for Health and Care Excellence published guidance recommending availability of minimally invasive sacroiliac joint fusion surgery to treat chronic sacroiliac pain.
Aesculap Launches Warranty for Plasmapore XP
Aesculap Implant Systems established a warranty program for its Plasmapore®XP-coated spinal interbody fusion devices, and launched the TSpace®XP interbody system.
SI-BONE Milestone: 25,000 iFuse Procedures Performed Worldwide
SI-BONE's iFuse Implant System® for SI joint fusion has been used in >25,000 procedures worldwide.
CoRoent Small Interbody Cleared for Cervical Disc Degeneration at up to 4 Levels
NuVasive received FDA 510(k) clearance to market the CoRoent® Small Interbody™ System for intervertebral body fusion at multiple contiguous levels in the cervical spine.
Providence Medical’s Recent FDA 510(k) Clearances
Providence Medical Technology received FDA 510(k) clearance for ALLY™ Facet Screws and for standalone use of the CAVUX™ Cervical Cage-L system.
Burst Biologics Spinal Fusion Study
Burst Biologics received IRB approval for a U.S. prospective clinical study of BioBurst cellular allograft in spinal fusion.
Alphatec Announces $18.9 Million Private Placement
Alphatec Spine entered into a definitive securities purchase agreement to raise ~US $18.9MM in a private placement.
Initial Procedures with Lucent XP Expandable Interbody Implant
Spinal Elements announced successful completion of initial procedures using the Lucent® XP expandable interbody device.
New Evidence-Based Recommendation for Lateral Interbody Fusion in UK
NuVasive announced updated guidance from the National Industry for Clinical Excellence in the U.K. for lateral lumbar interbody fusion.
Implanet Enters Exclusive Distribution Partnerships in Australia and New Zealand
Implanet announced integration of its Jazz Claw device into the Australian Register of Therapeutic Goods and entry into an exclusive partnership with Device Technologies for product distribution in Australia and New Zealand.
First Implantation of Spine Innovation Expandable Interbody Fusion Cage
Spine Innovation announced first implantations of its Expandable TLIF device.
Broader FDA Clearance for Spineology Elite Expandable Interbody Fusion System
Spineology received expanded FDA 510(k) clearance of the Elite Expandable Interbody Fusion system, to include a narrower 10mm version of the device and an indication for use with allograft bone.
Study Results: Vitrium Bioactive Glass in Ovine Spinal Fusion
Results from ovine study of Bio2 Technologies' Vitrium bioactive glass demonstrated the device's capability to support interbody fusion.
Three New Ex-U.S. Distribution Partners for VTI
Vertebral Technologies appointed new distributors in Finland, Germany and Sweden to expand access to InterFuse® modular interbody fusion implants.
Limited U.S. Launch of Arsenal Deformity Adolescent Scoliosis System
Alphatec Spine commenced limited U.S. launch of the Arsenal™ Deformity Adolescent Idiopathic Scoliosis system.
joimax Obtains Full Product Registration in Thailand
joimax obtained full product registration from the Thai Food & Drug Administration. Certification in Japan, Malaysia and Taiwan is expected during 2017.
Wenzel Spine Acquires PrimaLOK SP & FF Platforms from OsteoMed
Wenzel Spine acquired PrimaLOK™ SP Interspinous Fusion and PrimaLOK™ FF Facet Fixation systems from OsteoMed.
GS Medical USA Announces New Product Portfolio
GS Medical USA is launching AnyPlus® ACIF and the AnyPlus® Dual-Lead Pedicle Screw system in March 2017, to be followed by the AnyPlus® DLIF implant in 2Q17.
Nanovis Launches FortiCore PLIF
Nanovis completed alpha launch of FortiCore® PLIF, featuring a deeply-porous titanium scaffold with a PEEK core, and announced implantation of the 2,000th FortiCore implant.
DePuy Synthes Launches ViviGen Formable Cellular Bone Matrix
DePuy Synthes and LifeNet launched ViviGen Formable™ Cellular Bone Matrix, next-gen allograft to support bone formation during spinal fusion.
Strategic orthopaedic-related 510(k)s issued in January 2017
Strategic orthopaedic-related 510(k)s issued in January 2017 include: Fibulink Syndesmosis Repair Kit (Akros Medical), Anatomic Total Knee (Amplitude), Facilis Pedicle Screw System (Baui Biotech), GEO Bone Screw (Gramercy Extremity Orthopedics), Roccia ACIF Intervertebral Fusion System (Silony Medical), Fitbone TAA Intramedullary Lengthening System (Wittenstein Intens)
ChoiceSpine Launches Harrier ALIF System
ChoiceSpine launched HARRIER™, a PEEK-based anterior lumbar interbody fusion system.
Vertebral Technologies Enters GPO Contract
Vertebral Technologies entered into a GPO contract to provide modular interbody fusion devices to member facilities of Resource Optimization & Innovation/ROi.
Third FDA Clearance for Minuteman G3-R Implant
Spinal Simplicity received its third FDA 510(k) clearance for the Minuteman G3-R spinal implant.
SpineSource to Market Kisco’s L-Varlock Expandable Lumbar Cage
SpineSource entered into a long-term exclusive U.S. agreement to distribute Kisco International's L-Varlock® Expandable Lumbar Cage for vertebral interbody fusion.
Full Launch of SeaSpine’s Vu aPOD Prime NanoMetalene System
SeaSpine commenced full commercial launch of the Vu aPOD™ Prime NanoMetalene System for anterior lumbar interbody fusion.
DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screws
DePuy Synthes received FDA 510(k) clearance to market VIPER® and EXPEDIUM® Fenestrated Screw systems for use with cement to restore spinal column integrity in the treatment of advanced stage tumors.
Camber Spine FDA 510(k) Clearance for Siconus SI Joint Fixation
Camber Spine Technologies received FDA 510(k) clearance for the Siconus™ SI Joint Fixation System for the treatment of sacroiliac disease.
Study Results: iFuse vs. SI Joint Fixation with Screws
Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion patients receiving SI-BONE's iFuse™ vs. a 30.8% revision rate for those undergoing screw fixation.
Precision Spine Receives FDA 510(k) Clearance for ShurFit ACIF 2C System
Precision Spine received FDA 510(k) clearance of its ShurFit® ACIF 2C Anterior Cervical Interbody System, featuring a titanium + hydroxyapatite coating to support bone growth.
Retrospective Study: Spinal Elements’ Magnum+ ALIF Device With Ti-Bond Coating
Patients in a retrospective study of Spinal Elements' Magnum+® ALIF device with Ti-Bond® coating demonstrated a 96% success rate, with subjects achieving solid arthrodesis at an average of 7.3 ± 2.3 months.
Aurora Spine Issued U.S. Patent Related to Polyaxial ZIP Technology
Aurora Spine announced the allowance of U.S. Patent Application No. 14/732,240, "Polyaxial Interspinous Fusion Implant and Bone Growth Stimulation System.”
First Successful Spinal Implant in Mexico using VTi’s Interfuse
Vertebral Technologies announced a successful outcome in the first lumbar fusion procedure in Mexico using the InterFuse® laterally-expandable device.
Spinal Simplicity: Six New Patents Granted in 2016
Six new patents were granted to Spinal Simplicity in 2016, bringing its portfolio to 52 globally. A new Notice of Allowance in 2017 brings the company's U.S. patent total to 16.
Strategic orthopaedic-related 510(k)s issued in December 2016
Strategic orthopaedic-related 510(k)s issued in December 2016 include: Envision 3D Image Guidance System (7D Surgical); Sphynx Anterolateral Plate (Eden Spine); Destiknee Total Knee (Meril Healthcare); Hubble II Lumbar Interbody Fusion System (Orbbo Surgical)
Amedica’s First Taurus Pedicle Screw System Surgery
Amedica announced successful completion of the first surgery using the Taurus™ Pedicle Screw.
Medicrea Submits 510(k) for 3D-Printed Titanium Spinal Interbody Devices
Medicrea filed its FDA 510(k) submission for 3D-printed titanium interbody devices with compatible UNiD™ Lab surgical planning and analytical services.
Globus Medical Receives CE Mark for Excelsius GPS
Globus Medical received CE Mark approval for the Excelsius GPS™ robotic trajectory guidance and navigation system.
EU Patent for JAZZ Implant Universal Tensioning System
Implanet was granted a European patent for the JAZZ® implant universal tensioning system.
DePuy Synthes Acquires Interventional Spine Expandable Cage Technology
DePuy Synthes entered into an asset purchase and development agreement with Interventional Spine, addressing expandable fusion cages and a facet screw system for open and percutaneous spine surgery.
NuVasive to Resume XLIF Procedures in Japan in 1Q17
NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure.
Precision Spine Receives FDA 510(k) Clearance for AccuFit Lateral Plate
Precision Spine received FDA 510(k) clearance for the AccuFit® Lateral Plating System.
12-month Clinical and Radiographic Results with SImmetry Sacroiliac Joint Fusion
Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion procedure indicate that, at 12 months, fusion was reported in 88% of patients and back pain decreased by 46%.
New Indication for RTI Surgical’s C-Plus Peek IBF System
RTI Surgical's C-Plus™ PEEK Interbody Fusion system is now indicated for use with allograft, including the company's map3® cellular allogeneic bone graft.
MEDICREA’s 1,000 Patient-Specific UNiD Rod Procedure Milestone
Medicrea's patient-specific UNiD™ Rod technology has now been used in >1,000 procedures in Europe and the U.S.
Xtant Medical Receives FDA Clearance for Xsert Lumbar Expandable Interbody System
Xtant Medical announced FDA 510(k) clearance to market the Xsert™ Lumbar Expandable Interbody System. Initial product launch will commence in mid-2017.
Amedica Provides Regulatory Updates: Taurus and Valeo
Amedica's Taurus pedicle screw system has received FDA 510(k) clearance for marketing. First implantation and full market launch are slated to occur by year-end.
CMS Publishes 2017 Final Rule Increasing Outpatient Facility Reimbursement for MIS SI Joint Fusion
CMS issued its 2017 Final Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center payment rule for MIS sacroiliac joint fusion. New payments are effective January 2017.
DePuy Synthes Spine Introduces Zero-Profile Plate with Allograft Spacer
DePuy Synthes Spine launched the ZERO-P NATURAL™ Plate, designed for use with the CC Natural allograft spacer, for spinal fusion procedures in the neck.
Pre-clinical Study Results: Stryker’s 3D-printed Tritanium PL Interbody Cage
Results from a pre-clinical interbody fusion study of Stryker Spine's 3D-printed Tritanium PL Interbody Cage demonstrated statistically superior range of motion, bone in-growth and greater average construct stiffness vs. PEEK and titanium plasma-sprayed PEEK cages.
4WEB Medical Announces First U.S. Surgeries with Curved TLIF Device
4WEB Medical announced completion of first surgeries using the Curved Posterior Spine Truss system for TLIF procedures.
DePuy Synthes Launches SYNFIX Evolution for ALIF
DePuy Synthes Spine launched SYNFIX® Evolution for standalone Anterior Lumbar Interbody Fusion (ALIF).
Spineology Completes 100 Cases with Palisade Pedicular Fixation System
Spineology announced completion of 100 cases using the Palisade™ Pedicular Fixation System.
SeaSpine Receives FDA 510(k) Clearance for Shoreline ACS System
SeaSpine received FDA 510(k) clearance to market the Shoreline™ ACS Anterior Cervical Standalone system. Full commercial launch is slated for 1H17.
Medicrea Launches Lifetime Warranty for Patient-Specific UNiD Constructs
Medicrea will implement a lifetime warranty on its patient-specific UNiD™ technology implanted in the U.S. from 11/1/16.
Globus Medical Launched the QUARTEX™OCT Stabilization System and the INDEPENDENCE MIS™ integrated ALIF plate/spacer
Globus Medical launched the QUARTEX™ OCT Stabilization System and the INDEPENDENCE MIS™ integrated ALIF plate/spacer.
Tyber Medical Launches TyPEEK Lateral Implant
Tyber Medical commenced full launch of their lateral access, next-gen lateral PEEK/titanium composite interbody and lateral plating systems.
RTI Surgical Receives Additional 510(k) Clearance for Streamline OCT System
RTI Surgical received an expanded FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System, including an indication for polyaxial screw placement in the cervical spine, and also clearance for a dual diameter transition rod.
KB Medical Closes Series B Financing
KB Medical raised CHF 2.5MM (~US $2.51MM) in a Series B Financing. Funds will support FDA clearance for the AQrate™ Robotic Assistance System V 1.2 for spinal surgery.
Pinnacle Spine Launches InFill® V2 Lateral Interbody Device for Lumbar Spinal Fusion
Pinnacle Spine launched the InFill® V2 Lateral Interbody Device, featuring a large, single graft chamber and a large load-bearing surface area.
Genesys Spine to Debut TiLock Cortical Spinal System
Genesys Spine is launching the TiLock Cortical Spinal System to provide an anatomy-conserving alternative to traditional pedicular fixation.
Ascential Product and Service Offering to Launch
Ascential is launching to offer an implant and delivery solution for lower acuity spinal procedures in ambulatory surgery center and hospital settings. Implants are manufactured by Stryker.
Spineology Receives FDA Clearance of Rampart Duo Interbody Fusion System
Spineology received FDA 510(k) clearance to market the Rampart™ Duo™ Interbody Fusion System, reportedly the first device to combine PEEK, titanium and graft containment mesh elements.
DeGen Medical Launches Latitude-C Porous Ti Cervical Interbody Spacer
DeGen Medical introduced the Latitude-C™ Porous Ti Cervical Interbody Spacer.
Spine Wave Launches Velocity P Expandable Interbody Device
Spine Wave will commence full launch of the Velocity® P Expandable Interbody Device system in mid-November.
Initial Procedures with Spinal Elements’ Katana MIS Lateral System
Spinal Elements announced initial procedures using Katana™, its minimally invasive lateral system.
Early Outcomes with Porous PEEK COHERE Fusion Device
Vertera Spine announced initial successful outcomes using the COHERE® Cervical Interbody Fusion device.
12-month Fusion and Clinical Results with SImmetry Sacroiliac Joint Fusion
Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion with decortication procedure indicated fusion in 74% of patients, at 12 months.
Spineology Completes Limited Launch of Elite Expandable Interbody Fusion System
Spineology successfully completed limited launch of the Elite™ Expandable Interbody Fusion System.
Full U.S. Launch of New nanoLOCK Surface Technology from Titan Spine
Titan Spine commenced full U.S. distribution of Endoskeleton® titanium spinal interbody fusion implants featuring proprietary nanoLOCK® surface technology.
Titan Spine Raises $7.5 Million
Titan Spine raised US $7.5MM in Series D financing to support commercialization of nanoLOCK surface interbody devices.
FDA Clearance for Allograft Bone with Spineology Rampart Interbody Fusion Devices
Spineology received FDA 510(k) clearance for use of allograft bone with Rampart™ Interbody Fusion Devices.
Amedica Awarded New U.S. Patent
Amedica was awarded U.S. Patent No. 9,399,309 for threading sinterable materials, covering methods used for spinal fusion or other biomedical implants.
K2M Expands 3D-Printed MIS CASCADIA Lateral Interbody System
K2M received FDA 510(k) clearance for additional implant sizes of its CASCADIA™ Lateral Interbody System.
Positive Efficacy Data from ALLOB Phase IIA Spinal Fusion Trial
Bone Therapeutics reported positive efficacy data from its Phase IIA trial of ALLOB® in spinal fusion.
Phygen Receives Notice of Allowance on AutoLok Fixation Screw Assembly in U.S.
Phygen received a Notice of Allowance for the Leucadia AutoLok Fixation Screw Assembly under U.S. Patent Application No. 13/274,243.
Cerapedics Closes $11 Million Series D Financing
Cerapedics completed a US $11MM Series D financing to support expanded commercialization of i-FACTOR™ Peptide Enhanced Bone Graft.
Spineology Launches TLIF Insertion Options for Posterior Midline Approach ACT MediaLIF
Spineology launched a range of TLIF technologies for use with the Anatomy-Conserving Medial Lumbar Interbody Fusion platform (ACT MediaLIF™). These technologies support TLIF placement of interbody devices using a direct posterior approach.
Amendia Launches Syzygy™ Stabilization System
Amendia launched the Syzygy™ Stabilization System, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion.
ulrich medical USA Launches uCerv Titanium Cervical Interbody System
ulrich medical USA commenced U.S. launch of the uCerv® titanium spinal implant, an adjunct to its PEEK-based uCerv system for ACDF procedures.
Study Results from Inspired Spine’s MIS Direct Thoracic Interbody Fusion Procedure
Study results indicate that the minimally invasive direct thoracic interbody fusion or MIS-DTIF approach, offered by Inspired Spine, was shown to alleviate back pain in patients with degenerative disc disease or herniation.
Meditech Spine Receives FDA Clearance for CURE Anterior Cervical Plate
Meditech Spine received FDA 510(k) clearance to market CURE Anterior Cervical Plates to complement its Talos®-C (HA) interbody devices.
VTI Partners with Distributor in Mexico
Vertebral Technologies entered into a strategic partnership with BioMedical Technologies International to distribute InterFuse S™ and T™ spinal fusion devices throughout Mexico.
Globus Medical Completes Acquisition of Alphatec’s International Business
Globus Medical completed its acquisition of the international operations and distribution channels of Alphatec Spine for US $80.0MM in cash.
Life Spine Completes Initial Cases with SENTRY Lateral Plate
Life Spine announced successful completion of initial cases using the SENTRY™ Lateral Plate. Full launch will occur by the end of 2016.
Tyber Medical Launches a Lateral Plate
Tyber Medical commenced commercial launch of a low profile lateral plating system.
2-Year Results from SI-BONE iFuse INSITE Trial
Two-year results from a randomized, controlled trial in the management of sacroiliac joint dysfunction revealed that SI-BONE's iFuse yielded more rapid improvements in pain, disability and quality of life vs. non-surgical treatment.
FDA Clearance for New Sizes of Amedica’s Valeo II LLIF Device
Amedica received FDA 510(k) clearance for expanded sizes of the Valeo® II Lateral Lumbar interbody fusion device.
SeaSpine to Acquire NLT Spine, Expandable Interbody Platform Technologies
SeaSpine entered into a definitive agreement to acquire NLT Spine, developer of minimally invasive surgery devices. SeaSpine's commercial launch of the first NLT product is expected in 1H17.
Spinal Simplicity Introduces Next-Gen Minuteman G3 with HA Coating
Spinal Simplicity introduced a new generation version of the Minuteman G3 fusion device featuring an FDA-cleared hydroxyapatite coating.
Titan Spine Expands Distribution of Endoskeleton to Italy
Titan Spine expanded its agreement with MBA to include distribution of Endoskeleton® titanium implants in Italy.
Medtronic Completes $20MM Second Tranche Investment in Mazor Robotics
Medtronic completed the second tranche of equity investment in Mazor Robotics, as laid out in a previously-executed agreement.
Spine Wave Launches Velocity L Expandable Interbody Device and Enhanced Lateral System
Spine Wave introduced the Velocity™ L Expandable Interbody Device and next-generation lateral access technology.
Medicrea’s €20MM Financing to Support Patient-Specific UNiD Rods
Medicrea entered into agreements to raise €20MM (~US $22.4MM) to support commercialization of UNiD™ Patient-Specific Rods in the U.S. and new ex-U.S. markets.
Strategic Orthopaedic-related 510(k)s issued in July 2016
Strategic orthopaedic-related 510(k)s issued in July 2016 include: Integra External Fixation System (Ascension Orthopedics/Integra); CorticaLink Spinal Fusion Platform (FacetLink dba LinkSpine); Lumbar Interbody Fusion Device (Keos*); MectALIF Anterior Standalone Intervertebral Fusion Device (Medacta); Cure Anterior Cervical Plate (Meditech Spine); Cannulated Screw (Miami Device Solutions); Belvedere Lateral Plating System (NeuroStructures); NEO Arthroscope (Prosurg)
Spinal Elements Ti-Bond Implant Milestone and Warranty Program
Spinal Elements marked the milestone of >10,000 Ti-Bond interbody devices implanted and announced a 1-year warranty for Ti-Bond devices.
1,000th Case Using Vertical Spine’s FIBRINET Technology in Spinal Fusion
Vertical Spine achieved a milestone with the 1,000th case performed using its FIBRINET® System for the generation of Platelet-Rich Fibrin Membrane graft.
Orthofix Launches PHOENIX Minimally Invasive Spinal Fixation in Japan
Orthofix launched the PHOENIX® Minimally Invasive Spinal Fixation system in Japan.
Study Results: Trinity Evolution Allograft in Anterior Cervical Discectomy & Fusion
Data from a 12-month study of 1-level ACDF patients treated with Trinity Evolution® + a PEEK interbody spacer demonstrated fusion rates of 78.6% at 6 months and 93.5% at one year.
4WEB Medical Receives FDA Clearance of Lateral Spine Truss
4WEB Medical received FDA 510(k) clearance to market its Lateral Spine Truss interbody fusion device.
Ortho Kinematics Launches VMA-Align Diagnostic Module to Support Patient Selection
Ortho Kinematics launched VMA-Align, a diagnostic module that provides detailed spinal alignment measurements within the Vertebral Motion Analysis (VMA) product. The data is intended to assist in patient selection and planning for lumbar fusion.
Intellirod Spine Raises Over $1MM
Intellirod Spine raised >US $1.0MM in additional equity financing. Funds will be used to reach key milestones toward commercialization of sensor technologies and lumbar fusion implants.
Medtronic, Zimmer Biomet Enter 2-level Disc and Robotic Markets
Since mid-May, both Medtronic and Zimmer Biomet have announced strategic moves in the 2-level cervical disc replacement and robotic surgery markets. In efforts to invigorate revenue growth, the two have focused on niche technologies that should expand their portfolios-but have yet to prove wide scale.
NeuroPro Spinal Jaxx Receives FDA Clearance for Spinal Fusion Device
NeuroPro Spinal Jaxx received FDA 510(k) clearance to market the Spinal Jaxx expandable intervertebral spacer.
Zimmer Biomet to Acquire Medtech Surgical Robotics Company
Zimmer Biomet announced its plans to acquire Medtech, provider of surgical systems including the ROSA™ Spine robotic-assistive device for minimally invasive surgery.
First Implantation of Camber Spine’s Enza Zero-Profile ALIF Device
Camber Spine Technologies announced the first implantation of the ENZA™ MIS Zero-Profile ALIF device, occuring in a 2-level lumbar procedure.
Benvenue Announces 500th Spinal Fusion with Luna® 3D Interbody Fusion System
Benvenue Medical announced that >500 patients have been treated to date with the Luna® 3D Interbody Fusion System.
Amendia Launches Ceres™ Midline Cervical Plate
Amendia launched the Ceres™ Midline Cervical Plate, intended for anterior screw fixation of the cervical spine as an adjunct to fusion. The system designed for one and two-level surgeries and is available in 18 different length sizes.
Regulatory Clearance in Australia for Centinel Spine’s STALIF L
Centinel Spine received regulatory clearance in Australia for the STALIF L™ No-Profile, Lateral Lumbar Integrated Interbody system.
Initial Cases Complete with Life Spine’s LONGBOW Expandable Lateral Spacer
Life Spine announced successful completion of initial cases with LONGBOW™, the Expandable Lateral Spacer.
Aurora Spine Issued U.S. Patent Related to ZIP MIS Devices
Aurora Spine was issued U.S. Patent No. 9,364,264, "Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System," covering ZIP® devices including ZIP Ultra®, ZIP 51™, ZIP LP™, Dyna-ZIP™, etc.
Centinel Spine Completes Successful Evaluation of STALIF L
Centinel Spine completed the alpha release and commenced U.S. launch of STALIF L™ No-Profile, a lateral lumbar integrated interbody device.
Spinal Elements Receives FDA 510(k) Clearance for Expandable Interbody Device
Spinal Elements received FDA 510(k) clearance to market a line of expandable interbody fusion devices for posterior, anterior and lateral access to the lumbar spine.
Full Launch of Exactech’s Acapella One Cervical Spacer
Exactech commenced full launch of the Acapella® One Spacer, a cervical cage pre-assembled with integrated anchors to prevent device migration during anterior cervical fusion.
SI-BONE Closes $20MM Round of Growth Financing
SI-BONE closed a US $20MM round of growth capital financing. Proceeds will support U.S. sales expansion and R&D to develop new products to treat the SI joint.
Spineology Launches Elite Expandable Interbody Fusion System
Spineology released the Elite™ Expandable Interbody Fusion system, designed to be implanted at a minimal height and expanded after final positioning in the disc space.
Amendia Launches Ceres-C Standalone Cervical Interbody Device
Amendia commenced commercial launch of Ceres™-C, a low-profile standalone PEEK cervical interbody spacer designed for use in ACIF.
SeaSpine Introduces Hollywood VI NanoMetalene Interbody Device
SeaSpine commenced full commercial launch of the Hollywood™ VI (variable insertion) NanoMetalene® device for transforaminal lumbar interbody fusion.
Strategic Orthopaedic-related 510(k)s issued in May 2016
Strategic orthopaedic-related 510(k)s issued in May 2016 include: Navio Indication for TKA (Blue Belt Technologies), Enza Zero-profile Anterior Interbody Fusion System (Camber Spine), CSR Shoulder System (Catalyst OrthoScience*), Stropp/Single Tunnel Repair of Plantar Plate (CrossRoads Extremity), Cervical Interbody Fusion System (Evolution Spine*), Flip Button Suture Anchor (First Ray), Neofuse HA Enhanced PLIF/TLIF (HT Medical*), HC Spinal System (Hung Chun Bio-S*)
SI-BONE Receives 510(k) Clearance on Updated Indication for iFuse Implant
SI-BONE received FDA 510(k) clearance of a modified indication for the iFuse Implant System®, noting that clinical studies have demonstrated its ability to improve pain, patient function and quality of life.
Amedica Submits Response to FDA for Clearance of Composite Interbody Spinal Device
Amedica submitted its responses to FDA in relation to the CASCADE clinical trial, and expects a final determination from FDA within 60 days.
Xtant Medical, Pinnacle Spine Distribution Agreement
Xtant Medical and Pinnacle Spine entered into a joint agreement to expand distribution of Pinnacle's InFill® Lateral Lumbar Interbody Fusion system.
Zimmer Biomet Acquiring LDR
Zimmer Biomet entered into a definitive agreement to acquire LDR for US $37/share in cash, for a transaction valued at ~$1.0BB with an expected 3Q16 close.
First Implantations of Vertera Spine Porous PEEK COHERE Cervical Fusion Device
Vertera Spine announced first implantations with the COHERE™ Cervical Interbody Fusion system. Full market launch is expected in coming months.
Life Spine’s Initial Cases and Multiple Surgeries with PLATEAU-Ti Spacer
Life Spine announced successful completion of initial cases with the PLATEAU®-Ti Spacer, a titanium interbody system featuring OSSEO-LOC™ surface treatment to support potential bone growth.
Pinnacle Spine Launches InFill ALIF
Pinnacle Spine launched the InFill® Anterior Lumbar Interbody Fusion device, compatible with the InFill Graft Delivery System.
K2M Receives FDA Clearance for CASCADIA Cervical, AN Lordotic Oblique Interbody Systems
K2M received FDA 510(k) clearances to market CASCADIA™ Cervical and CASCADIA AN Lordotic Oblique Interbody systems, featuring Lamellar 3D-printed Titanium Technology™.
Centinel Spine Expands MIDLINE II-Ti in U.S. and Australia
Centinel Spine expanded its MIDLINE II-Ti product family, a Ti-ACTIVE™ coated, No-Profile, anterior lumbar Integrated Interbody device, in the U.S. and Australia.
Interventional Spine Announces FDA Clearance of Lordotic Opticage™
Interventional Spine announced FDA clearance of the 80 Lumbar Lordotic Opticage™, an intervertebral body fusion device for use with autogenous bone graft in patients with degenerative disc disease.
Medtronic Announces U.S. Launch of Spine Essentials
Medtronic commenced U.S. launch of Spine Essentials™, implants and instruments designed to lend efficiency to the most common cervical fusion procedures.
Orthofix Announces FDA Clearance, Limited Launch of FORZA PTC Interbody Spacer
Orthofix announced FDA 510(k) clearance and U.S. limited launch of the FORZA® PTC™ (Peek Titanium Composite) Spacer.
Initial Cases Performed with Life Spine PROLIFT Expandable Interbody System
Life Spine announced successful completion of initial cases with the PROLIFT® Expandable Interbody System for minimally invasive PLIF, TLIF and oblique approaches.
Camber Spine Receives FDA Clearance for ENZA Zero Profile ALIF Device
Camber Spine Technologies received FDA 510(k) clearance to market the ENZA™ Zero Profile Anterior Interbody Fusion system.
MEDTECH Announces First U.S. ROSA Spine Surgery
MEDTECH announced the first procedure using the ROSA™ Spine robot in the U.S.
SI-BONE’s iFuse Surpasses 20,000 Surgeries
Since launch in 2009, SI-BONE's iFuse Implant System® has been used in >20,000 procedures worldwide. The product was recently launched in Australia and New Zealand.
Spinal Simplicity Gains Investor Support from Nueterra
Spinal Simplicity closed a financing round with an investment from Nueterra Capital. Funds will support U.S. launch of the Minuteman fusion device to treat low back pain.
Wenzel Spine Launches VariLift-LX
Wenzel Spine commenced full U.S. launch of the VariLift®-LX expandable standalone interbody fusion device.
Intelligent Implant Systems Receives 510(k) Clearance for 2-Level Revolution System
Intelligent Implant Systems received FDA 510(k) clearance to market 2-level components for the Revolution™ Spinal System, allowing for use in 2-level posterior thoracolumbar fusion.
New Product Launches from NuVasive
NuVasive announced launch of new products such as AttraX® Putty Biotextured™ bone graft, the Reline® Modular system, next-gen MAS® TLIF 2 technology, etc.
Pinnacle Spine Granted Chinese Patent for InFill Spinal Fusion Technology
The Chinese Patent Office is issuing Patent Application No. 201180020517.1, "Intervertebral Implants and Graft Delivery Systems and Methods," as an enforceable patent for Pinnacle Spine, covering InFill® fusion technology.
Study Results Show Benefits of SI Joint Fusion after Two Years
Results from a 2-year study of SI-BONE's iFuse implant for sacroiliac (SI) joint fusion show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years.
First Clinical Cases with Life Spine’s GRUVE Anterior Cervical Plate
Life Spine announced initial clinical cases with the GRUVE™ Anterior Cervical Plate. Full launch is slated for 2Q16.
RTI Surgical Launches Deformity Instrumentation for Streamline TL Spinal Fixation System
RTI Surgical launched deformity instrumentation for the Streamline® TL Spinal Fixation system for treatment of complex adult deformities or curvatures in the thoracolumbar spine.
K2M MESA Mini and DENALI Mini Spinal Systems Receive Additional FDA Clearance in Posterior Cervical Spine
K2M received FDA 510(k) clearance for expanded indications of its MESA® Mini and DENALI® Mini spinal systems for stabilization of the posterior cervical and thoracic spine as an adjunct to fusion.
Interventional Spine Launches Next-Gen Opticage Lumbar Interbody Fusion Implants
Interventional Spine launched its next-generation Opticage® Lumbar Fusion line, including recent size additions and lordotic versions.
SpineSource Launches Expandable Lumbar Interbody Cage in U.S.
SpineSource commenced U.S. launch of the titanium alloy L-Varlock Lumbar Cage, reportedly the only expandable interbody that can adjust in situ from 0° to 24° of lordotic angle and up to 7mm of expansion.
Zyga Enrolls First Patients in Expanded Clinical Study on Sacroiliac Joint Fusion
Zyga Technology enrolled the 1st 4 patients in an expanded EVoluSIon Clinical Study evaluating long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.
Renovis Surgical Receives FDA Clearance of Tesera SC Cervical Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera™ SC porous titanium cervical interbody fusion system.
Wenzel Spine Announces Limited Release of the Next-Gen VariLift-LX
Wenzel Spine commenced limited launch of the VariLift®-LX system for minimally invasive lumbar fusion. Full launch is planned for spring 2016.
NuVasive Receives Regulatory Approval of ReLine™ Posterior Fixation in Japan
NuVasive received regulatory approval for ReLine™ posterior fixation technology in Japan. Launch will commence later in 2016 and continue into 2017.
Nanovis Receives NIH Research Grant
Nanovis received an NIH grant supporting pre-clinical studies of FortiCore® deeply-porous interbody fusion devices, enhanced with nanotube technology.
Medtronic Launches AVILA Interbody Fusion Devices in the EU
Medtronic commenced EU launch of AVILA™ devices, intended for use in open and minimally invasive anterior and oblique lumbar interbody fusion from L2-S1 levels.
Life Spine Receives FDA Clearance for PROLIFT Expandable Interbody System
Life Spine received FDA 510(k) clearance to market the PROLIFT® Expandable Interbody System for use in minimally invasive PLIF, TLIF and oblique approaches.
ulrich medical USA Launches uNion Cervical Plate
ulrich medical USA launched uNion®, a titanium alloy cervical plate for stabilization and anterior fixation as an adjunct to fusion.
Xtant Medical Receives CE Mark for Aranax and Irix-A
Xtant Medical received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.
Stryker Launching Xia 4.5 Cortical Trajectory Line for LITe LIF Procedures
Stryker Spine is launching Xia 4.5 Cortical Trajectory implants and instruments for LITe® Lumbar Interbody Fusion.
Amedica and Celling Biosciences to Collaborate on Spinal Fusion Devices
Amedica and Celling Biosciences will co-develop spinal fusion devices based on silicon nitride technology plus stem cell-based therapies.
Stryker Spine Launching Aero-C Cervical Stability System
Stryker Spine is launching the Aero®-C Cervical Stability System, reportedly the only ACDF device to offer uniform compression across the interbody space.
Bone Biologics Completes $5.75 Million Funding Round
Bone Biologics completed a US $5.75MM funding round to support development of a bone graft substitute for initial focus on spinal fusion.
Spine Wave Licenses Patents from Atlas Spine
Spine Wave licensed True Position® Pivoting Interbody Spacer IP from Atlas Spine.
RTI Surgical Announces Limited Launch of Unison-C Anterior Cervical Fixation System
RTI Surgical commenced limited launch of the Unison™-C anterior cervical fixation system.
ALLOB Phase IIA Spinal Fusion Trial Update
Bone Therapeutics has treated 12 patients in the ALLOB® Phase IIA spinal fusion trial, and reports no safety concerns.
National Government Services Issues Coverage for MIS SI Joint Fusion
National Government Services issued a positive local coverage determination for MIS SI joint fusion, including SI-BONE's iFuse procedure, effective 4/1/16.
Strategic Orthopaedic-related 510(k)s issued in January 2016
Strategic orthopaedic-related 510(k)s issued in January 2016 include: Half Dome PLIF System (Astura Medical*), Cannulated Screw System (Epic Extremity*), Rosa Spine (Medtech*), IFS Fixation Scaffold (Metric Medical), dynaMX MX Tabbed Staple (MX Orthopedics), Hard Carbon Coated Drill Bit (Renovo Life*), Polyscrew Pedicle Fixation System (Senecka Spine*), Interbody System (Spine Innovation*), VerteLP IBF Device (VGI Medical*)
Wenzel Spine Receives FDA 510(k) Clearance for VariLift-LX
Wenzel Spine received FDA 510(k) clearance to market VariLift®-LX as a lumbar interbody fusion device for standalone use.
Amendia Launches OmegaLIF™ Expandable Interbody Cage
Amendia launched OmegaLI
HAPPE Spine Gains Additional U.S. Patent
The patent claims provide broad protections for material and manufacturing that support fully porous, bioactive polyetheretherketone technology.
Spinal Elements Gains FDA Clearance of Sapphire X Anterior Cervical Fixation
While MIS procedures typically focus on incision size, MIS Ultra considers post-op implications such as disruption of skeletal and muscle tissue.
CoreLink Gains FDA Clearance of Stand-Alone Cervical System
F3D-C2 features the only 3D-printed technology with both a trabecular structure and directional support lattices.
SeaSpine Launches Mariner MIS and Outrigger Fixation
Combined with Midline and Adult Open systems, Mariner offers one product platform to perform open, MIS, hybrid, revision and adjacent segment procedures.
Orthofix Gains FDA Clearance for FIREBIRD SI Fusion
The 3D-printed bone screw is designed to relieve pain from sacroiliac joint dysfunction.
Xenco Launches CancelleX Titanium Foam Spine Implants
CancelleX bio-inspired spinal implants are the first injection-molded titanium foam implants for spine surgery pre-attached to disposable instruments.
Pantheon Surgical Acquires Blue Topaz, CompresSIve Technology
Pantheon Surgical acquired the technology from Osseus Fusion Systems, which will continue to distribute the Blue Topaz/CompresSIve system.
Carlsmed Raises Funds to Support aprevo System
The financing supports clinical launch of the aprevo system, which makes surgical plans and devices tailored to the needs of each patient.
SeaSpine Launches NorthStar OCT and Cervical Facet Fusion Systems
SeaSpine announced limited commercial launches and completion of initial surgeries with the NorthStar OCT and Cervical Facet Fusion systems.
joimax Partners with Distributor JAPAN MEDICALNEXT
JMC, located in Osaka, Japan, distributes orthopedic products with application in sports medicine, joint replacement, fracture fixation, etc.
NuVasive Launches Reline 3D for Pediatric Deformity
Reline 3D is designed to simplify spinal deformity procedures by allowing surgeons to drive simultaneous, three-dimensional correction.
icotec Gains Clearances for KONG VBR Spinal Systems
KONG-TL and KONG-C, featuring Titaniumcoating (Ti-iT®), received FDA 510(k) clearance in the U.S. and CE Mark approval in Europe.
Spinal Elements Introduces the MIS Ultra Platform of Products and Procedures
The MIS Ultra™ platform of products and procedures is designed to optimize spinal fixation and restoration and minimize unintended consequences of surgery.
Zavation Medical Launches Cortical Screw
The device is designed to achieve greater cortical bone purchase with a smaller midline incision when using Cortical Bone Trajectory.
Providence Medical Enrolls in FUSE IDE Study
FUSE is designed to demonstrate superiority of Circumferential Cervical Fusion vs. traditional ACDF in patients at high risk for nonunion or revisions.
MiRus Shares First Clinical Use of 3DR Printed Lumbar Interbody Fusion
The 3DR Printed Lumbar Interbody Fusion System is designed with a randomized lattice structure that mimics the organic structure of bone.
Augmedics xvision Used in First U.S. Spinal Fusion
Surgeons used the augmented reality system to visualize anatomy with simulated “x-ray vision” and to accurately guide instruments and implants.
4WEB Medical Gains FDA Clearance for Stand-Alone Anterior Lumbar Interbody Fusion
The company is expanding its Anterior Spine Truss System with the addition of integrated fixation.
OrthoPediatrics Launches ApiFix Deformity Correction
ApiFix provides options for the minimally invasive treatment of progressive adolescent idiopathic scoliosis in the U.S.
Precision Spine Launches Reform Ti Modular Pedicle Screw
The system offers options of increased flexibility, versatility and visibility in degenerative and trauma spinal procedures.
BRICON and PINA Medizintechnik to Merge
The companies' portfolios of cervical and lumbar spinal products are complementary. BRICON is based in Germany and PINA in Switzerland.
Patient Confidence Improving but Situation Remains Fluid
SI-BONE’s iFuse SI Fusion Implant Covered by Aetna
The positive coverage policy further validates acceptance of iFuse as a treatment option for patients with chronic sacroiliac joint dysfunction.
Medacta Announces First Surgery with Mecta-C Stand Alone Device and New Registrations
Mecta-C Stand Alone has also obtained CE Mark approval in Australia, and will soon be launched there and select areas in Europe.
Nexxt Spine Gains FDA Clearance for ALIF and Lateral Systems
ALIF launches August 2020 and Lateral in September 2020. An integrated plate system is slated for for each product in 4Q.
Life Spine’s First Cases with DYNA-LINK Ti Stand-Alone ALIF Spacer
DYNA-LINK Ti features the company's proprietary OSSEO-LOC™ surface technology and large, open graft windows.
Axis Spine Gains FDA Clearance for Axis-ALIF
Axis has developed a platform technology of build in situ modular cages as an alternative to conventional designs.
Zavation Medical Launches eZspand Expandable Cage
The lumbar interbody fusion device offers continual expansion to optimize the fit for each patient.
Precision Spine Launches the Reform Ti HA Coated Pedicle Screw
The system's screws feature a titanium tulip and a triple lead thread to offer strength and stability to all thoracolumbar constructs.
Neo Medical Raises Funding for Growth in Spinal Fusion
Neo Medical has developed a universal surgical platform, including five instruments and fourteen implants covering most spine indications.
Precision Spine Launches Slimplicity HP Anterior Cervical Plate
Precision Spine commenced U.S. launch of the Slimplicity® HP Anterior Cervical Plating (ACP) System, which accommodates diverse patient anatomies and pathologies with low profile constrained, semi-constrained or hybrid constructs....
NuVasive in Strong Position to Weather the COVID-19 Storm
Camber Spine Launches New Anterior Cervical Plates
The SPIRA-C Standalone Integrated Interbody and the FORTICO Anterior Cervical Plate are FDA 510(k)-cleared and ready for U.S. launch.
COVID-19 Derails SI-BONE’s Record Procedure Trajectory in 1Q20
NuVasive Expands Advanced Materials Science Implant Portfolio
The AMS implant portfolio includes proprietary surface and structural technologies to enhance biomechanical properties of materials for spine procedures.
Precision Spine Launches ShurFit 2C Interbody Systems
ShurFit 2C features a coating of titanium and hydroxyapatite to help increase durability support fixation during biologic fusion.
Life Spine Gains FDA Clearance for Additions to ARx
The clearance addresses implant and instrument additions to the system. ARx is Life Spine's fourth 510(k) clearance in 2020 with 92 total since inception.
Nanovis Awarded FDA Clearance for Nano FortiFix Pedicle Screw
This is the first pedicle screw system with a Nanotechnology designation and osteoblast/stem cell data comparing performance to other surface types.
Atlas Spine Gains FDA Clearance for Expandable Stand-Alone Cervical Interbody
HiJAK SA joins first-to-market HiJAK AC and the V3 segmental plating system as the latest technology in Atlas Spine's disruptive design portfolio.
Spineway Signs Exclusive Contract with MURANAKA Medical Instruments
With this agreement, Spineway can deploy its implants in one of the largest markets in spine and accelerate its sales with higher added value.
Life Spine PROLIFT Lateral Fixated System Gains FDA Clearance
The system is complemented by Life Spine's full Lateral portfolio including the CENTRIC® Plier Style Retractor and Lateral Disc Prep.
Precision Spine Launches Reform MC Posterior Lumbar Fusion System
The Reform MC is a top-loading, multiple component, posterior spinal fixation system with cannulated pedicle screws, straight and lordotic rods and locking cap screws.
DePuy Synthes Down 7.5%, Bracing For More Extreme Declines
Hyprevention Receives FDA Clearance for V-STRUT Vertebral Implant
With the V-STRUT system, two PEEK polymer implants are inserted in the vertebral body through the pedicles and combined with PMMA bone cement to treat VCFs.
Signus Medizintechnik Gains CE Mark for BIG ST ALIF Cage
Signus Medizintechnik announced CE Mark approval for the BIG® ST ALIF Cage and JASPIS® ST Cervical Cage, additions to the company's Structural Titanum portfolio of 3D-printed cages.
Precision Spine Launches Reform Ti Titanium Pedicle Screw
Precision Spine globally launched the Reform® Ti Titanium Pedicle Screw for degenerative and trauma spine procedures.
NuVasive Issues Field Safety Notice for MAGEC System
NuVasive voluntarily issued an Urgent Field Safety Notice in the U.K. and Ireland to address concerns identified by The Medicines and Healthcare Products Regulatory Agency over continued use of the MAGEC device for the treatment of scoliosis.
Nexxt Spine Launches Nexxt Matrixx Corpectomy
Nexxt Spine received FDA 510(k) clearance of the Nexxt Matrixx® Corpectomy System, and commenced product launch.
Safe Orthopaedics Gains Japan Approval of Next-Gen SteriSpine PS
Safe Orthopaedics received regulatory approval of SteriSpine™ PS 2nd Generation in Japan.
OrthoPediatrics Gains Expanded Indications for RESPONSE Scoliosis System
OrthoPediatrics was granted FDA 510(k) clearance to expand indications for the RESPONSE™ Scoliosis System to include neuromuscular implants.
Safe Orthopaedics’ Key Patents Confirmed in Europe
The European Patent Office confirmed the strength of certain of Safe Orthopaedics' patents following an opposition procedure by Neo Medical.
Alpha Launch of ChoiceSpine’s RAVEN Lateral Lumbar Plate
ChoiceSpine commenced alpha release of the RAVEN™ Lateral Lumbar Plate.
Precision Spine Launches SureLOK MIS 3L Percutaneous Screw
Precision Spine commenced U.S. launch of the SureLOK™ MIS 3L Percutaneous Screw.
SI-BONE Double Digit Growth Fueled by Reimbursement Wins
NuVasive Attrax Putty Study Results
Study results support the use of NuVasive's Attrax® Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion.
ATEC Outperforms Expectations With 24% Growth In 2019
Medacta Gains FDA Clearance for Mecta-C Stand Alone ACIF Implant
Medacta received FDA 510(k) clearance to market the Mecta-C Stand Alone Implant.
Life Spine Gains Additional FDA 510(k) for Lateral PROLIFT Expandable System
Life Spine received an additional FDA 510(k) clearance for the Lateral PROLIFT® Expandable System.
Amplify Surgical Announces 300th Level Treated with dualX Expanding Interbody
Amplify Surgical's dualX™ Expanding Interbody Fusion System has been implanted in 300 surgical levels to date. Initial alpha launch commenced in 1Q19.
AO Foundation and icotec Developing Spinal Stabilization
The AO Foundation and icotec will jointly develop a new spinal stabilization system based on icotec's BlackArmor® Carbon/PEEK composite material.
ATEC to Acquire EOS imaging
Alphatec/ATEC entered into an agreement to acquire EOS imaging for nearly USD $122 million in cash and equity. The transaction is slated to close in 3Q20.
RTI Surgical SImmetry System Interim Study Results
RTI Surgical's SImmetry® sacroiliac fusion system yielded evidence of fusion in 98% of treated joints, per interim study results.
NuVasive Hits $1 Billion in Spine Sales for 2019
Globus Notches Third Straight Year of Double-Digit Growth in 2019
restor3D Raises $4.3 Million in Equity Funding
restor3D raised USD $4.4 million in equity. The company develops 3D-printed implants, and entered into a development and licensing agreement with SeaSpine in late 2019.
Genesys Spine Launches Sacroiliac Joint Fusion System
Genesys Spine introduced its Sacroiliac Joint Fusion system, which gained FDA 510(k) clearance in 3Q19.
Late-Quarter Infuse Headwinds Blunt Medtronic’s Growth
Medicrea Gains FDA Clearance for Patient-Matched Interbody Cages
Medicrea was granted FDA 510(k) clearance for UNiD® IB3D Patient-Matched interbody cages.
INSPAN Reports Study Results from Inspan Interspinous Fixation Device
INSPAN announced successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan® ScrewLES™ Fusion interspinous fixation device.
CTL Amedica Granted Patent for Screw Offset Blocking Mechanism Used in MONET Anterior Cervical Fusion
CTL Amedica was granted a U.S. patent addressing a screw offset blocking mechanism that is used in the company's MONET™ Anterior Cervical Fusion System.
Tenon Medical’s Catamaran SI Fixation Study Results
Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System demonstrated an over 85% reduction in SIJ pain at six weeks, with radiographic evidence of solid continuous bridging bone across the treated joint at six months.
Life Spine Gains FDA Clearance of Steerable PLATEAU Ti Interbody
Life Spine gained FDA 510(k) clearance for the Steerable PLATEAU® Ti System.
Globus Medical’s First Case with HEDRON IA ALIF Spacer
Globus Medical announced the first implantation of HEDRON IA, a 3D-printed integrated anterior lumbar interbody fusion spacer.
Medicrea Reaches 5,000 Cases with UNiD ASI Technology
Medicrea achieved the milestone of more than 5,000 procedures using the UNiD® ASI platform and patient-specific spinal implants.
Osseus Fusion Debuts Aries-TS TLIF Device
Osseus Fusion Systems commenced alpha launch of the Aries™-TS 3D-printed transforaminal lumbar interbody fusion device.
SpineCraft Launches ASTRA OCT Spine System
SpineCraft completed the ASTRA product platform with launch of its Occipito-Cervico-Thoracic system for use in posterior cervical fusion.
Atlas Spine Launched V3 Guided Segmental Cervical Plate
Atlas Spine launched the V3 Guided Segmental Plating System to treat complex deformity and degenerative conditions of the cervical spine.
DePuy Synthes Accelerates Commitment to Digital Surgery in 2020
Inspired Spine Reaches 1,000 OLLIF Procedure Milestone
Inspired Spine achieved the milestone of completion of 1,000 Oblique Lateral Lumbar Interbody Fusion procedures.
CoreLink Hits Milestone of 5,000 Implants with 3D-Printed Technology
CoreLink has implanted over 5,000 3D-printed spinal devices that employ proprietary Mimetic Metal® additively-manufactured technology.
Cutting Edge Spine Gains FDA Clearance of EVOLha-DLIF
Cutting Edge Spine received FDA 510(k) clearance of the EVOL®ha-DLIF direct lateral interbody fusion system.
Medicrea Awarded 7 New U.S. Patents
Medicrea was issued seven additional U.S. patents related to its proprietary UNiD™ Adaptive Spine Intelligence technology platform.
SeaSpine Launches Mariner Midline Posterior Fixation
SeaSpine commenced the full commercial launch of the Mariner® Midline Posterior Fixation System, a less-invasive option to treat a range of spinal pathologies.
SeaSpine Marks 25,000th NanoMetalene Implantation
SeaSpine announced the implantation of the 25,000th NanoMetalene® interbody device.
Study Results: RTI Surgical’s TETRAfuse 3D PEKK Technology
Studies show that RTI Surgical's TETRAfuse® PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time and a significantly higher push-out strength vs. standard PEEK.
Curexo Launches Robot-Assisted Spine Surgery Device
Curexo launched the CUVIS-spine robot-assisted spine surgery device in Korea.
CIGNA Establishes Positive Coverage for MIS SI Joint Fusion
CIGNA announced a positive coverage policy for minimally invasive sacroiliac joint fusion exclusive for FDA-cleared implants that are placed across the SI joint, such as SI-BONE's iFuse Implant System.
ulrich medical USA Launches Momentum Posterior Spinal Fixation
ulrich medical USA launched the Momentum™ Posterior Spinal Fixation System.
Medtronic Introduces Mazor X Stealth Edition in India
Medtronic launched the Mazor X Stealth Edition™ Robotic-Assisted Spine Surgery System in India.
ATEC Launches SafeOp Neural InformatiX System
ATEC Spine commenced full commercial launch of the SafeOp Neural InformatiX System™.
Aurora Spine Sales Decline on Product Line Cannibalization
Life Spine Gains FDA Clearance for LONGBOW Titanium Spacer
Life Spine was granted FDA 510(k) clearance to market the LONGBOW® Titanium Lateral Expandable Spacer.
Entry Into Joint Replacement a Major Step in Globus Medical’s Evolution
NuVasive Gains Additional FDA Clearance for CoRoent Small Interlock
NuVasive received FDA 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system.
DePuy Synthes Launches SYMPHONY OCT System
DePuy Synthes launched the SYMPHONY Occipito-Cervico-Thoracic System, expanding its offering for the treatment of conditions in the neck and upper spine.
4WEB Medical Launches Stand Alone Cervical Spine Truss
4WEB Medical commenced limited launch of the Cervical Spine Truss System-Stand Alone™ (CSTS-SA) implant.
Medtronic’s Surgical Synergy Strategy Accelerates Growth in Spine
Life Spine’s CENTERLINE Modular Spinal System in Limited Launch
Life Spine commenced limited launch of the CENTERLINE® Modular Thoracolumbar Spinal System, and announced initial surgeries. Full launch is slated for early 2020.
Medicrea Growth Driven by U.S. Sales of Patient-Specific Implants
Globus Medical Double-Digit Growth Driven by Spinal Hardware and ExcelsiusGPS
Zimmer Biomet Gains Momentum on ROSA Knee and Increased Supply
CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion
CMS increased the Medicare Physician Fee Schedule for CPT® Code 27279, Arthrodesis Sacroiliac Joint, under which minimally invasive sacroiliac joint fusion procedures are reported.
RTI Surgical Reduces Guidance Due to Softer than Expected coflex Sales
Spineology U.S. Fusion Trial 24-Month Outcomes Data
Two-year outcomes from Spineology's SCOUT trial of the OptiMesh® device revealed substantial improvements in low back pain and function scores at 6, 12 and 24 months.
DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial
DiFusion received FDA 510(k) clearance for the Xiphos-ZF spinal interbody device made from ZFUZE biomaterial. Product launch will occur within 4Q19.
U.S. Spinal Hardware Sales Continues to Drive NuVasive Growth
Alphatec Spine Continues Success Story with New Product Launches and a Revitalized Sales Channel
Spinal Implant Growth Drives SeaSpine to Record Revenues
Stryker Gains FDA Clearance for SAHARA Lateral 3D Expandable Interbody
Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.
Safe Orthopaedics SteriSpine LC and CC Gain Japan Regulatory Approval
Safe Orthopaedics received regulatory approval for SteriSpine™ LC lumbar and CC cervical cages in Japan.
Nanovis Gains FDA Clearance for Bioceramic Nanotube Surface
Nanovis received the first FDA 510(k) clearance for a bioceramic nanotube surface that demonstrates FDA's requirements for nanotechnology.
Implanet Granted Patent in Japan for JAZZ Lock
Implanet was granted a patent in Japan for JAZZ Lock® technology, part of its JAZZ™ solutions platform to treat degenerative spine disorders.
Alphatec Launches IdentiTi for Lateral Interbody Fusion
Alphatec launched IdentiTi™ porous titanium implants for lateral interbody fusion procedures.
CarboFix Gains FDA Clearance for Carbon Fiber VBR
CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber Vertebral Body Replacements.
DePuy Synthes Up 1.2% in 3Q19 on Trauma Growth
Spineway Mont Blanc MIS Approved in Japan
Spineway obtained regulatory approval in Japan for its Mont Blanc minimally invasive surgical devices.
Zimmer Biomet Launches TrellOss-TC Porous Titanium Interbody System
Zimmer Biomet launched the TrellOss™-TC Porous Titanium Interbody, completing its initial offering of porous titanium implants.
HD LifeSciences Announces Fluid Channels Patent Allowance
HD LifeSciences received a patent allowance notice addressing fluid channel technology employed in its interbody fusion devices.
Aegis Spine Gains FDA Clearance for AccelFix Expandable Cage
Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage System.
Viseon’s First Clinical Use of Voyant Lateral System
Viseon announced the first clinical use of Voyant Lateral visualization to support real-time imaging during a minimally invasive lateral lumbar procedure.
Amplify Surgical Announces 100th Level Treated with dualX Expanding Interbody
Amplify Surgical marked the milestone of 100 surgical levels implanted with the dualX™ Expanding Interbody Fusion System.
Spineology Raises $7MM in Equity
Spineology raised $7MM of a potential $16MM round of equity funding.
Back 2 Basics Gains FDA Clearance for Carbon Interbody Cages
Back 2 Basics received FDA 510(k) clearance to market eCarbon anterior cervical and posterior lumbar Interbody devices.
Alphatec Up 24% in 2Q19 on Revitalized Sales Channel
SeaSpine Announces 20,000th NanoMetalene Implantation
SeaSpine marked the implantation of the 20,000th NanoMetalene® interbody device.
MiRus Gains FDA Clearance for CYGNUS Anterior Cervical Plate
MiRus received FDA 510(k) clearance to market the molybdenum alloy-based CYGNUS Anterior Cervical Plate.
Life Spine Gains Additional FDA 510(k) Clearance for PROLIFT Expandable Spacer
Life Spine received an additional 510(k) market clearance from FDA for the PROLIFT® Expandable Spacer System, addressing new sizes.
The Spine Market: A Look at Past and Forecasted Performance
Spine is the largest individual segment that we track, accounting for 18.2% of the orthopedic industry's overall revenue. Excluding biologics, sales of orthopedic spine products topped $9.3 billion in 2018, growing +2.7% vs. 2017. Growth in the segment exceeded our expectations, as several companies in the top 10 posted double-digit increases that offset lower performance by manufacturers at the top of the list. Here, we take a deeper look at past, present and forecasted performance.
FDA 510(k) Recap: Spinal Devices and Technologies from 1H19
With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.
NanoFUSE Launches NanoSTRIP 100% Bioactive Glass Synthetic Biologic
NanoFUSE commenced market release of NanoSTRIP, a 100% bioactive glass synthetic biologic strip indicated for spine and orthopedic use.
Centinel Spine Successfully Surpasses 1,000 Implantations with FLX Interbody Devices
Centinel Spine announced 1,000 implantations of FLX 3D-printed porous titanium interbody devices since initial launch in 3Q18.
Alphatec Launches InVictus Spinal Fixation
Alphatec commenced commercial release of InVictus, a spinal fixation platform to treat a range of pathologies via MIS, open or hybrid surgical approaches.
Alphatec Launches IdentiTi Interbody for ALIF
Alphatec commenced commercial release of the IdentiTi Large Window Porous Titanium Interbody Implant for anterior lumbar interbody fusion.
joimax Launches EndoLIF Line
joimax commenced launch of the complete line of EndoLIF® devices for lumbar interbody fusion.
Osseus Fusion Systems Acquires SIJ Surgical
Osseus Fusion Systems acquired SIJ Surgical, developer of a sacroiliac fusion screw.
Safe Orthopaedics’ SteriSpine Used in First Surgeries in Japan
Safe Orthopaedics' SteriSpine pedicle screw kits have been utilized in 23 procedures in Japan since launch in May 2019.
SeaSpine Launches Regatta Lateral System
SeaSpine commenced full launch of the Regatta® minimally invasive lateral interbody fusion system.
Implanet reports 2Q19 revenue of €1.9MM (USD $2.2MM), +8.4% vs. 2Q18
icotec Gains FDA Clearance for VADERone Pedicle Screw
icotec was granted FDA 510(k) clearance for VADER®one pedicle screws for minimally invasive and open spine procedures.
Celling Spine Acquires Assets of Link Spine
Celling Spine acquired all assets of Link Spine, and will develop spinal fusion hardware to complement its own orthobiologic product portfolio.
Medtronic Completes Acquisition of Titan Spine
Medtronic closed its acquisition of Titan Spine, developer of Endoskeleton® interbody devices and nanoLock® surface technology.
SI-BONE’s iFuse Surpasses 40,000 Procedures
SI-BONE's iFuse Implant System®, introduced in 2009, has been used in >40,000 SI joint fusion procedures by more than 1,900 surgeons worldwide.
Benvenue Medical Gains FDA Clearance for Luna XD MIS Expandable Interbody
Benvenue Medical received FDA 510(k) clearance for the Luna® XD MIS expandable interbody device. Controlled launch will proceed at select centers.
Innovasis Gains FDA Clearance of LxHA Spinal Fusion System
Innovasis was granted FDA 510(k) clearance to market the LxHA Lateral Interbody Fusion Device.
Implanet Books First Orders Supporting Kico Knee and SeaSpine Partnerships
Implanet received its first orders related to its distribution agreements with Kico Knee Innovation and SeaSpine.
Life Spine Gains FDA Clearance for PROLIFT Lateral Expandable Spacer
Life Spine received FDA 510(k) clearance to market the PROLIFT® Lateral Expandable Spacer system.
NuVasive Launches Modulus TLIF-O Porous Titanium Spine Implant
NuVasive commenced launch of Modulus® TLIF-O, a porous titanium implant for transforaminal lumbar interbody fusion.
Medicrea Awarded Additional U.S. Patents
Medicrea was allowed three new U.S. patents relating to the company's proprietary UNiD® Adaptive Spine Intelligence software platform.
ulrich medical USA to Surpass 100,000 VBR Implant Milestone in 2019
ulrich medical USA is slated to achieve the milestone of 100,000 total vertebral body replacement device implantations within the year.
RTI Surgical Milestone for Fortilink Interbody Fusion Systems
RTI Surgical achieved the milestone of 5,000 implants of Fortilink®-C, -TS and -L interbody fusion systems in the U.S.
Implanet Announces First U.S. JAZZ Cap Procedures
Implanet's JAZZ® Cap device has been successfully used in first U.S. spinal fusion procedures.
Zavation Receives FDA Clearance for Ti3Z Interbody
Zavation received FDA 510(k) clearance to market the Ti3Z lumbar interbody system.
Ozop Surgical Update on Adjustable ALIF Interbody Implant
Ozop Surgical has completed initial testing of a novel adjustable ALIF interbody spinal implant.
Globus Medical Launches AERIAL Expandable Interspinous Fixation
Globus Medical introduced AERIAL, a minimally invasive expandable interspinous fixation system.
Aurora Spine Reports 1Q19 Revenue of $2.7MM, +81.2% vs. 1Q18
Alphatec Launches TLIF IdentiTi Posterior Curved Porous Titanium Interbody
Alphatec launched the IdentiTi-PC Porous Titanium Interbody Implant for TLIF.
Medtronic Reports FY 4Q19 Orthopedic Revenue of $862.9MM, +4.9% vs. 4Q18
Camber Spine Announces 1Q19 Sales Results +22% vs. 1Q18
M&A Recap: Three 2Q Announcements in Spine
Of the 20 OEM-related M&A announcements we've covered in 2019 thus far, seven have related to the spine market. Of those, three were announced in rapid succession within this quarter. Let's see who bought whom, and what they got: Medtronic/Titan Spine, Boston Scientific/Vertiflex and WishBone Medical/CSpine.
CoreLink Launches Lateral Access and Interbody Fusion Platform
CoreLink introduced a lateral access and interbody fusion platform comprising tissue retractor options and F3D titanium alloy and CL5 PEEK lateral interbody implants.
Alphatec Spine Reports 1Q19 Revenue of $24.6MM, +15.3% vs. 1Q18
Innovasis HA PEEK Data Registry Reaches Milestone of 150 Enrollees
Innovasis' HA PEEK Data Registry achieved significant enrollment of 150 patients since its 2018 launch.
ChoiceSpine Gains FDA Clearance for Two Cervical Spinal Fusion Devices
ChoiceSpine received FDA 510(k) clearance to market the TIGER SHARK C interbody device and the BOOMERANG Anterior Cervical Plate.
SI-BONE Reports 1Q19 Revenue of $15MM, +17.9% vs. 1Q18
Medtronic Enters Agreement to Acquire Titan Spine
Medtronic entered into a definitive agreement to acquire Titan Spine, a titanium spine interbody implant and surface technology company.
WishBone Medical Acquires CSpine
WishBone Medical purchased CSpine, manufacturer of spine and orthopedic implants and instruments.
Globus Medical Reports 1Q19 Revenue of $182.9MM, +4.9% vs. 1Q18
NuVasive Reports 1Q19 Revenue of $274.8MM, +5.5% vs. 1Q18
Alphatec Launches PLIF IdentiTi Posterior Straight Interbody and AlphaGRAFT DBM Fiber
Alphatec launched the PLIF IdentiTi-PS Porous Titanium Interbody for PLIF, and AlphaGRAFT® DBM Fiber.
SeaSpine Reports 1Q19 Revenue of $36.2MM, +9% vs. 1Q18
Aurora Spine Reports 4Q18 Revenue of $2.5MM, +82.4% vs. 4Q17
ApiFix Completes Series B Financing
ApiFix completed its Series B financing round and is preparing for U.S. commercial launch of its MID-C System to treat pediatric scoliosis.
Safe Orthopaedics’ SteriSpine PS Gains Japan Regulatory Approval
Safe Orthopaedics received regulatory registration in Japan for the SteriSpine PS system to treat spinal fractures.
NuVasive Cohere Porous PEEK Comparative Study Results
NuVasive's Cohere® Porous PEEK interbody demonstrated clear benefits in promoting improved early outcomes in ACDF procedures when compared to both structural allograft and smooth PEEK.
SI-BONE Gains FDA Clearance of iFuse Bedrock Fixation Technology
SI-BONE received an additional FDA 510(k) clearance for use of iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.
Medicrea Reports 1Q19 Revenue of €7.7MM, +10.6% vs. 1Q18
NuVasive Debuts X360 System for Lateral Single-Position Spine Procedures
NuVasive is introducing the X360 system integrated with Pulse automation for lateral single-position surgery.
NASS Review: Spinal Robotics, Enabling Technologies, 3D Printing and Biologics
Enabling technology was the story of the North American Spine Society 2019 annual meeting (NASS), with the top spine players heavily featuring their robotic-assisted surgery ecosystems.
ChoiceSpine HAWKEYE Ti VBR Cleared for All Spine Segments
ChoiceSpine received expanded FDA 510(k) clearance for the HAWKEYE Ti vertebral body replacement for use in the cervical spine.
NuVasive Proprietary Porous PEEK Used In First XLIF Cases
NuVasive announced initial XLIF® spinal procedures using the Cohere® XLIF lateral Porous PEEK device.
Alphatec Launches IdentiTi Porous Titanium Interbody Cage
Alphatec announced commercial release of the IdentiTi-C Porous Titanium Interbody for ACDF.
SpineEX Issued New U.S. Patent
SpineEX was issued its second U.S. patent, addressing a novel mechanism to adjust posterior and anterior sides of an interbody fusion device independently of each other.
MiRus Gains FDA Clearance for Molybdenum Rhenium Pedicle Screw
MiRus received FDA 510(k) clearance for the Europa pedicle screw made of MoRe® molybdenum rhenium superalloy material.
SpineEX Receives Additional FDA Clearance for Sagittae LLIF
SpineEX gained additional FDA clearance for the Sagittae Lateral Lumbar Interbody Fusion system, covering new instrumentation and an updated surgical technique.
RTI Surgical Enrolls 1st Patient in FORTE Clinical Study of Fortilink Interbody
RTI Surgical enrolled the first patient in FORTE, a clinical evaluation of the Fortilink® interbody fusion device in the treatment of degenerative disc disease. Enrollment is slated for completion in 1Q20.
Implanet Gains FDA Clearance for JAZZ Cap
Implanet received FDA 510(k) clearance to market JAZZ Cap® to secure screws in poor quality bone in vertebral fusion procedures.
iOrthopedics Introduces the Gobi Expandable Spine Cage
iOrthopedics introduced the Gobi Spine Cage, evolving from its Uniformly Expanding Cage patents toward 50% expansion uniformly, proximally or distally.
Kuros Biosciences Gains FDA Clearance for Intervertebral Body Fusion Device
Kuros Biosciences received FDA clearance to market the Kuros TLIF cage.
SI-BONE reports 4Q18 revenue of $15.6MM, +13% vs. 4Q17
Amplify Surgical’s dualX Dual Expanding Interbody Fusion Used in First Cases
Amplify Surgical completed initial surgical cases with the dualX Dual Expanding Interbody Fusion System.
SeaSpine Reports 4Q18 Revenue of $38MM, +11.9% vs. 4Q17
Atlas Spine Launches HiJak AC Expandable Interbody
Atlas Spine announced successful completion of its 50th surgical procedure and >100 devices implanted with the HiJak AC expandable cervical interbody fusion device.
4WEB Medical Expands Surgeons Users by 20%
Alphatec Gains FDA Clearance for SafeOp Neuromonitoring
Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.
Safe Orthopaedics Launches Essential Instrument Kit
Safe Orthopaedics launched Essential, a kit containing all of the instruments needed to perform a percutaneous spinal fracture repair.
OrthoPediatrics Launches BandLoc DUO
OrthoPediatrics introduced BandLoc DUO, the latest addition to the BandLoc 5.5/6.0mm spinal repair system.
NuVasive Reports 4Q18 Revenue of $288.3MM, +6.3% vs. 4Q17
Globus Medical Reports 4Q18 Revenue of $195.9MM, +11.3% vs. 4Q17
SeaSpine, Implanet Form US Partnership with Jazz Spinal Devices
Implanet entered into a U.S. private label distribution agreement with SeaSpine covering the Jazz® portfolio of spinal devices.
SpineGuard Achieves DSG Technology Milestone
SpineGuard marked the 70,000th spinal procedure using DSG® real time digital technology for surgical guidance.
Medtronic Reports FY 3Q19 Orthopedic Revenue of $739.8MM, -0.3% vs. 3Q18
Carevature Completes 1,000 Procedures with Dreal Technology
Carevature Medical achieved a milestone of 1,000 procedures using the Dreal® decompression platform.
Life Spine Launches SIMPACT SI Joint Fixation Study
Life Spine initiated an outcomes study for SIMPACT® Sacroiliac Joint Fixation.
Alphatec Announces Stay of Proceedings In NuVasive Patent Lawsuit
Alphatec announced favorable developments in its ongoing patent litigation with NuVasive regarding CoRoent® lateral implants.
iOrthopedics: Patents Expected for 3D Printing of Universally Expanding Cage
iOrthopedics continues to expand its IP portfolio, with pending patents directed to methods of 3D printing its Universally Expanding Cage interbody device.
Southern Spine Launches Thoracic Dual Lamina Implants for StabiLink Interlaminar System
Southern Spine commenced full launch of three StabiLink® Dual Lamina implants, designed for upper thoracic procedures. The company also announced three additional U.S. patents for its StabiLink® MIS Interlaminar Spinal Fixation System.
Spineart’s 1,000 Perla Posterior Cervical Surgery
Spineart reached the milestone of 1,000 Perla procedures performed in the U.S.
Aesculap Implant Systems PlasmaporeXP Surface Enhancement Study
Studies of Aesculap Implant Systems' Plasmapore®XP Surface Enhancement indicate that early bone-forming activity was upregulated in osteoblast-like cells that attached to the PlasmaporeXP.
Aurora Spine Granted U.S. Patent for Minimally Invasive Spinal Devices
Aurora Spine was granted a U.S. patent, œExpandable Interspinous Device, covering the company's family of minimally invasive spinal implants.
DePuy Synthes Reports 4Q18 Revenue of $2,205.1MM, -0.5% vs. 4Q17
Medicrea Reports 4Q18 Revenue of €8MM, +33.3% vs. 4Q17
Centinel Spine Completes Initial Cases Using FLX 3D Printed Lateral Lumbar Interbody System
Centinel Spine has completed initial procedures with its newest implant system in the FLX platform of Integrated Interbody 3D-printed interbody fusion devices.
HoloSurgical’s ARAI Used in Spinal Fusion Procedure
HoloSurgical announced a successful first in human procedure utilizing the ARAI augmented reality and artificial intelligence-based navigation system.
SpineSource Acquires Implant Systems from Kisco
SpineSource acquired the IP assets of two spinal implant systems from Kisco International, including the L-VARLOCK® expandable lumbar cage.
ulrich medical USA Launches Solidity Expandable VBR
ulrich medical USA announced U.S. launch of the Solidity expandable vertebral body replacement.
Spineology Duo LIF Commercial and Postmarket Update
Spineology surpassed completion of 125 lateral interbody fusion cases with the Duo system.
Medtronic Completes Acquisition of Mazor Robotics
Medtronic completed its planned acquisition of Mazor Robotics in a transaction valued at US $1.7BB.
OrthoPediatrics’ Launch of RESPONSE 4.5/5.0mm System
OrthoPediatrics commenced full U.S. launch of the RESPONSE 4.5/5.0mm system for the treatment of complex scoliosis.
NuVasive Gains FDA Clearance for Monolith Corpectomy
NuVasive received FDA 510(k) clearance to market an expanded indication for the Monolith® corpectomy system in the cervical spine.
ZygoFix Launches zLOCK Facet Fixation Study
ZygoFix announced the successful start of a first in human clinical study of zLOCK facet joint fixation.
Blue Cross Blue Shield of Arizona Covers SI BONE iFuse Implant System
SI-BONE's iFuse Implant System received exclusive coverage from Blue Cross Blue Shield of Arizona.
Nexxt Spine Launches SAXXONY Posterior Cervical Thoracic System
Nexxt Spine grows its fusion portfolio with launch of the SAXXONY® Posterior Cervical Thoracic system.
SI-BONE reports 3Q18 revenue of $13.4MM, +14.5% vs. 3Q17
Safe Orthopaedics Study: Cost Savings with Single-use Instruments
Study results revealed an average 50% cost-per-patient savings with use of Safe Orthopaedics' instruments vs. reusable ones in the treatment of spinal fractures.
Zimmer Biomet Recalls Spinal Fusion and Long Bone Stimulators
Zimmer Biomet initiated a recall of 1,360 units of the Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator and SpF-XL Implantable Spinal Fusion Stimulator devices.
ChoiceSpine Acquired by Altus Capital
ChoiceSpine, a manufacturer of devices and biologics used to treat complex spine disorders, was acquired by Altus Capital Partners.
Medicrea Reports 3Q18 Revenue of €7.3MM, +14.1% vs. 3Q17
HealthPartners Covers RTI’s SImmetry SI Joint Fusion
HealthPartners, the largest consumer-governed nonprofit healthcare organization in the U.S., issued a positive coverage decision for minimally invasive sacroiliac joint fusion surgery, expanding patient access to RTI Surgical's SImmetry System.
Aurora Spine Gains Access to SI Fusion Patent
Aurora Spine acquired an exclusive license to a U.S. patent pertinent to sacroiliac joint repair.
NuVasive Launches Brigade for ALIF Surgery
NuVasive announced U.S. commercial launch of the Brigade® Lateral device for lateral anterior lumbar interbody fusion.
Camber Spine: First Procedures with ENZA-A Titanium ALIF
Camber Spine successfully completed its first procedures with the ENZA-A Titanium Anterior Lumbar Interbody Fusion system.
Bio2 Gains Approval to Study Vitrium in Interbody Fusion
Bio2 Technologies received FDA approval to enroll subjects in an IDE clinical study of Vitrium bioactive glass as a cervical interbody fusion device.
Alphatec Spine Reports 3Q18 Revenue of $23MM, -0.4% vs. 3Q17
Globus Medical Reports 3Q18 Revenue of $169.2MM, +11.5% vs. 3Q17
K2M Reports 3Q18 Revenue of $71.4MM, +13.9% vs. 3Q17
SeaSpine Reports 3Q18 Revenue of $35.8MM, +12.9% vs. 3Q17
NuVasive Gains FDA Clearance for COHERE in XLIF
NuVasive received FDA 510(k) clearance for the COHERE® Porous PEEK device in eXtreme Lateral Interbody Fusion.
Stryker Completes K2M Acquisition
Stryker closed the previously-announced $1.4BB acquisition of K2M.
Spinal Elements Receives Additional FDA 510(k) Clearance for Ti-Bond Coating Technology
Spinal Elements received additional FDA 510(k) clearance for claims related to the macro-, micro- and nano-surface structure of its Ti-Bond® surface coating technology.
iOrthopedics Awarded Additional Patent for Universally Expanding Cage
iOrthopedics was granted U.S. Patent No. 10,085,846 for its Universally Expanding Cage interbody device.
OrthoPediatrics Reports 3Q18 Revenue of $15.8MM, +27.8% vs. 3Q17
RTI Surgical Acquiring Paradigm Spine
RTI Surgical entered into a definitive agreement to acquire Paradigm Spine in a cash and stock transaction valued at up to US $300MM.
Innovasive Gains FDA Clearance for DualX Expanding Interbody
Innovasive received FDA 510(k) clearance to market the DualX titanium dual expanding interbody device for lumbar fusion procedures.
NuVasive Reports 3Q18 Revenue of $271.3MM, +9.6% vs. 3Q17
Orthofix Reports 3Q18 Revenue of $111.7MM, +6.1% vs. 3Q17
Life Spine’s First Clinical Cases with PROLIFT Post Pack Expandable Interbody
Initial clinical cases have been performed with Life Spine's PROLIFT® Post Pack expandable interbody system.
Camber Spine Reaches $1MM Milestone with SPIRA-C
Aurora Spine Granted EU Patent for ZIP Minimally Invasive Spinal Devices
Aurora Spine was granted an EU Patent covering ZIP® interspinous devices.
SI-BONE Closes Initial Public Offering
SI-BONE closed its previously-announced initial public offering of 8,280,000 shares of common stock, priced at US $15 per share. The company is now trading on Nasdaq with the ticker symbol SIBN.
OrthoPediatrics Gains FDA Clearance for Small Stature Scoliosis System
OrthoPediatrics received FDA 510(k) clearance to market the RESPONSE 4.5/5.0mm system to treat complex scoliosis in smaller stature patients.
K2M Expands MESA Platform with FDA Clearance for Sagittal Imbalance Application
K2M received additional FDA 510(k) clearance for the MESA® Spinal System, supporting use of sagittal plane correction in idiopathic scoliosis.
SpineEX Gains FDA Clearance for Sagittae LLIF
SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar interbody fusion.
NuVasive Enters Partnership with Biedermann Technologies
NuVasive entered into a strategic partnership with Biedermann Technologies to integrate proprietary screw technology into NUVA's RELINE® portfolio, for 1H19 launch.
Safe Orthopaedics Posts 3Q18 Revenue Growth of 20%
ApiFix System Reaches 250-Patient Milestone in Scoliosis Correction
The ApiFix Minimally Invasive Deformity Correction (MID-C) technology for correction of Adolescent Idiopathic Scoliosis has been used in 250 patients to date.
SI-BONE Announces UK Guidance Recommendation for iFuse
The U.K.'s National Institute for Health and Care Excellence published medical technology guidance recommending SI-BONE's iFuse® for the treatment of chronic sacroiliac joint pain.
Amedica Closes Sale of Spine Portfolio to CTL Medical
Amedica completed the sale of its spine business to CTL Medical, which is now exclusive owner of the metal and silicon nitride spine product portfolio.
Alphatec Gains FDA Clearance for OsseoScrew
Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw.
Renovis Surgical Receives FDA Clearance for Tesera X Lateral Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera® X Lateral Interbody Fusion system.
4WEB Partners with Tedan, Lattus on Total Lateral Solution
4WEB Medical entered into an exclusive partnership with Lattus Spine and TeDan Surgical Innovations to co-market a turnkey Total Lateral Solution, with retractor and implant.
NuVasive Enrolls Patients in Advanced Materials Science in XLIF Study
NuVasive commenced patient enrollment in a prospective, multicenter U.S. study evaluating advanced spinal implants used in XLIF® procedures.
SeaSpine Launches Regatta Lateral System
SeaSpine commenced full launch of the Regatta® minimally invasive lateral interbody fusion system.
Medtronic Launches Infinity OCT Spinal System
Medtronic commenced U.S. launch of the Infinity OCT system for posterior cervical fusion.
Nexxt Spine Clinical Trial Evaluating 3D Printed Ti vs. PEEK
Nexxt Spine commenced a clinical trial evaluating Nexxt Matrixx® 3D-printed lumbar interbody fusion devices vs. PEEK cages.
CoreLink Launches FLXfit15 Articulating Expandable Posterior Lumbar Interbody
CoreLink Surgical launched the FLXfit®15 articulating expandable intervertebral body fusion device.
SI-BONE Files for Proposed IPO
SI-BONE publicly filed for a proposed IPO, and applied to list on NASDAQ as SIBN. Proceeds will primarily support commercialization activities for the iFuse implant for treatment of SI joint dysfunction.
Providence Medical Technology Secures $25MM in Equity Financing
Providence Medical Technology closed US $25MM in new equity financing. Proceeds will support market expansion and clinical development of DTRAX® posterior cervical fusion instruments.
NICE Recommendation for TranS1 AxiaLIF in the UK
TranS1 announced NICE recommendation for approval of the AxiaLIF® system and presacral approach among standard arrangments to treat severe chronic low back pain.
SpineEx Files for $17MM IPO
SpineEx filed to raise up to US $17MM in an initial public offering to support commercialization of spinal devices, including an expandable cage for lateral lumbar fusion.
Meditech Spine Gains FDA Clearance for Cure Opel-C Plating System
Meditech Spine gained FDA 510(k) clearance to market the CURE Opel-C Plate implant system, an add-on technology to its CURE anterior cervical plate system and Talos-C HA interbody systems.
NuVasive Launches MAGEC X in UK
NuVasive commenced U.K. launch of MAGEC X, an extension of its MAGEC line to treat Early Onset Scoliosis.
Spine Wave Launches Paramount Anterior Cervical Cage
Spine Wave commenced full launch of the titanium Paramount® Anterior Cervical Cage for interbody fusion.
SpineVision Gains FDA Clearance, CE Mark for HEXANIUM TLIF Cage
SpineVision received FDA (510)k clearance and CE Mark approval for the 3D-printed HEXANIUM TLIF cage.
Captiva Spine Gains FDA Clearance for TowerLOX-EXT Tab Pedicle Screws
Captiva Spine announced FDA 510(k) clearance for the TowerLOX-EXT® MIS Extended Tab pedicle screw.
JNJ Acquires Emerging Implant Technologies
Johnson & Johnson Medical Devices is acquiring Emerging Implant Technologies, a manufacturer of 3D-printed titanium interbodies for spinal fusion.
Genesys Spine Gains FDA Clearance for AIS-C Interbody System
Genesys Spine announced FDA 510(k) clearance and launch of the AIS-C Stand-Alone interbody system for cervical spine.
NASS Conversations Reaffirm Spine’s Focus on Additive, Computer-Assisted, Materials
The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials and manufacturing.
Captiva Spine Gains FDA Clearance for TirboLOX-L Cage
Captiva Spine announced FDA 510(k) clearance and launch of the TirboLOX-L 3D-printed titanium lumbar cage.
4WEB Medical Reports 73% YOY Increase in Adoption of Lateral Spine Truss
4WEB Medical achieved a 73% YOY increase in surgeon adoption of its Lateral Spine Truss System.
NuVasive Launches TLX 20 Expandable Interbody
NuVasive commenced U.S. launch of the TLX® 20 Expandable interbody implant for use in lumbar procedures.
Eden Spine Gains FDA Clearance for SPHYNX Thoracolumbar Plate
Eden Spine received FDA 510(k) clearance to market the SPHYNX thoracolumbar locking plate.
Stryker Acquiring K2M
Stryker entered into a definitive merger agreement to acquire K2M for ~US $1.4BB in cash. The transaction is slated to close in 4Q18. For 2017, K2M posted revenue of $249.3MM, +8.8% vs. 2016.
SI-BONE Gains Exclusive Positive Coverage for iFuse in France
SI-BONE's iFuse® system for sacroiliac joint fusion will be added to the List of Refundable Products and Services in France, and has exclusive French National Healthcare System coverage.
Centinel Spine Completes Initial Cases Using FLX 3D Printed Titanium Interbodies
Centinel Spine completed initial cases with three different implant portfolios within its FLX platform of Integrated Interbody and non-integrated 3D-printed interbody fusion devices.
Nanovis Completes $5.5MM Funding Round
Nanovis completed a US $5.5MM funding round. Proceeds will support sales and distribution of FortiCore® interbody fusion devices.
Amedica Announces First Valeo C+CSC Procedure
Amedica marked completion of the first spinal fusion using the Valeo® C+CSC with Lumen interbody fusion device.
Osseus Fusion Gains FDA Clearance for 3D-Printed Lumbar IBFs
Osseus Fusion Systems received FDA 510(k) clearance to market Aries 3D-printed lumbar interbody fusion devices.
CoreLink Gains FDA Clearance for Foundation 3D ALIF
CoreLink received FDA 510(k) clearance to market the Foundation 3D Anterior Lumbar Interbody Fusion device.
Zavation Launches Facet, SI Screw Systems
Zavation commenced launch of its Facet screw and Sacroiliac screw systems.
Orthofix Reports 2Q18 Revenue
Alphatec 2Q18 Revenue
Fuse Medical Acquires Maxim Surgical
Fuse Medical acquired Maxim Surgical, a manufacturer of spinal fusion devices.
Globus Medical Reports 2Q18 Revenue
K2M Announces 2Q18 Revenue
NuVasive 2Q18 Revenue +8.5% vs. 2Q17
OrthoPediatrics Announces Expanded Indication for FIREFLY Pedicle Screw Navigation
OrthoPediatrics announced an additional FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide to include S2AI screw trajectory for sacral-iliac fixation in complex spinal reconstruction.
SeaSpine 2Q18 Revenue +7% vs. 2Q17
Zimmer Biomet Ortho Revenue +4% vs. 2Q17
CarboFix Gains FDA Clearance for Pedicle Screw
CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological patients.
Stryker Posts 2Q18 Revenue Growth of 8% YoY
ORTHOWORLD estimates Stryker's 2Q18 orthopaedic revenue at US $1,747.8MM, +8.0% from 2Q17, and 1H18 revenue at $3,472.6MM, +7.5% vs. 1H17. Trauma and Extremities Joint Recon remain high performers, with Interventional and Tritanium products contributing to strong spine segment growth.
DePuy Synthes Launches CONCORDE LIFT Expandable Interbody
DePuy Synthes commenced U.S. launch of the CONCORDE LIFT Expandable Interbody, part of the UNLEASH MIS TLIF Procedural Solution.
Implanet Opens Subsidiary in Germany
Implanet established a subsidiary in Germany, furthering its strategy to expand sales in the European market.
FBC Device Gains FDA Clearance for Interbody Implant
FBC Device received its first FDA 510(k) clearance, granted for the FBC 921 ALIF interbody implant.
ReVivo Medical Efficacy Study Results
Results from an efficacy study of ReVivo Medical's spinal fusion technology demonstrated that loadsharing through elastic micro-motion accelerates bone formation and interbody fusion.
HAPPE Spine Forms to Develop PEEK Interbody Implants
HAPPE Spine has formed to develop technology that supports construction of partial or fully porous hydroxyapatite-reinforced PEEK implants.
NuVasive Launches MAGEC X for Early Onset Scoliosis
NuVasive commenced U.S. launch of MAGEC X, an extension of its MAGEC line to treat Early Onset Scoliosis.
K2M Gains FDA Clearance, CE Mark Approval for CAYMAN United Plate
K2M received FDA 510(k) clearance and CE Mark approval for the CAYMAN® United Plate.
Vallum Gains FDA Clearance of Nanotextured PEEK Interbody
Vallum received FDA 510(k) clearance to market a PEEK interbody fusion device with a PEEKplus® nanotextured surface created with proprietary Accelerated Neutral Atom Beam technology.
NuVasive Launches Reline Low-Profile Modular Implants
NuVasive introduced the Reline® MAS® Midline® cortical pedicle screw system for posterior fixation.
Life Spine Launches CENTRIC-T Pedicle-Based Retractor
Life Spine commenced limited launch and announced first clinical use of the CENTRIC®-T Pedicle-Based Retractor for minimally invasive TLIF.
Cutting Edge Spine Gains FDA Clearance for EVOL ha-C Interbody
Cutting Edge Spine received FDA 510(k) clearance to market the EVOL ha-C cervical interbody system.
Medicrea Launches Australian Subsidiary
Medicrea entered into a joint venture with National Surgical to offer its products in Australia and New Zealand.
NuVasive Broadening Expandable Portfolio with Lateral Procedures
NuVasive is launching the XLIF® Lordotic Expandable interbody system for XLIF anterior column realignment, a minimally disruptive alternative to open procedures.
Life Spine’s Robotic Assisted Tools Used in ASC
Life Spine announced the first ASC procedures using robotic-assisted placement of CENTERLINE® Cortical Screws and PROLIFT® Expandable Spacers.
GS Medical Launches AnyPlus MIS Pedicle Screw System
GS Medical commenced U.S. launch of the AnyPlus® Extended Tab system for minimally invasive pedicle screw placement.
Renovis Surgical Gains FDA Clearance for New Tesera ALIF System
Renovis Surgical Technologies received FDA 510(k) clearance to market Tesera® SA Hyperlordotic ALIF, a standalone interbody fusion system.
Globus Medical Milestone: 3,000 Screws Implanted with ExcelsiusGPS
Globus Medical marked a milestone with successful implantation of >3,000 screws with ExcelsiusGPS® robotic guidance and navigation since late-2017 launch.
Tenon Medical Gains FDA Clearance for Catamaran Sacroiliac Joint Fixation
Tenon Medical received FDA 510(k) clearance to market the Catamaran Sacroiliac Joint Fixation system, indicated for sacroiliac joint fusion to treat joint disruptions and degenerative sacroilitis.
Study Validates NuVasive’s Porous PEEK Cohere
Study results indicate that NuVasive's porous PEEK technology, used in the Cohere® cervical interbody fusion device, presents a clinically viable option to improve osseointegration and fusion.
OrthoPediatrics Announces First RESPONSE Spine Procedure in Japan
OrthoPediatrics marked the first spine surgery in Japan with the RESPONSE spine system.
Globus Medical Launches CREO Cement Augmented Pedicle Screw
Globus Medical launched the CREO® Fenestrated Screw, designed for use with FORTRESS bone cement to treat thoracolumbar spinal tumors.
RTI Surgical Launches Fortilink-TS and -L Interbody Fusion Systems
RTI Surgical launched Fortilink®-TS and -L lumbar interbody fusion systems, which feature TETRAfuse® 3D printed polymer.
Safe Orthopaedics Enters Distribution Agreement with KiSCO for Japan
Safe Orthopaedics entered into an exclusive commercialization and distribution agreement in Japan with KiSCO.
Medacta Marks First US Surgery with MUST SI Joint Screw
Medacta announced the first surgery performed in the U.S. using the Medacta Unconstrained Screw Technology Sacro-Iliac Joint Screw (M.U.S.T. SI) for sacroiliac joint fusion.
Centinel Spine Gains FDA Clearance of FLX 3D Printed Titanium Interbodies
Centinel Spine received FDA 510(k) clearance to market the FLX platform of Integrated Interbody and non-integrated interbody fusion devices.
K2M Launches 100th Product
K2M achieved the milestone of its 100th product following FDA 510(k) clearance and launch of the OZARK Cervical Plate.
CoreLink Acquiring Expanding Orthopedics
CoreLink has acquired Expanding Orthopedics, developer of the FLXfit line of expanding interbody devices. Terms were not disclosed.
Implanet Opens UK Sales Branch
Implanet opened a branch in the U.K. to support expansion and growth in the adult degenerative spine market.
Spineology Rampart One Standard ALIF Interbody Gains Standalone FDA Clearance
Spineology received FDA 510(k) clearance to market the Rampart One Standard ALIF device without supplemental fixation.
Camber Spine Gains FDA Clearance for ENZA-A Titanium ALIF
Camber Spine received FDA 510(k) clearance to market the ENZA-A Titanium Anterior Lumbar Interbody Fusion system.
iOrthopedics Reports Patent Awards and Allowances
iOrthopedics has received patent awards and allowances for its Universally Expanding Cage, giving exclusive rights in the expandable interbody arena.
Medicrea Gains FDA Clearance for Patient-Specific Spinal Cage
Medicrea obtained what is reported to be the first FDA 510(k) clearance to market patient-specific spinal cages.
Safe Orthopaedics Acquires UK Distributor Qspine
Safe Orthopaedics will acquire the salesforce of U.K. distributor Qspine.
Medtronic Revenue Grows 3.7%
K2M Receives FDA Clearance for BACS Patient-Specific Module
K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices.
Medacta Launches Customizable MySpine MC Surgical Guides
Medacta announced FDA 510(k) clearance and launch of the MySpine Midline Cortical Pedicle Screw Placement Guide.
Implanet Launches JAZZ Evo® for Adult Degenerative Spine Disease
Implanet launched JAZZ Evo® for adult vertebral fusion. The device is the first in a new range of JAZZ® connectors.
Life Spine Gains FDA Clearance for PRO-LINK Ti Stand-Alone Cervical Spacer
Life Spine received FDA 510(k) clearance to market additional indications for the PRO-LINK® Ti Stand-Alone Cervical Spacer.
Wenzel Spine Announces Case Study of VariLift-LX System
Wenzel Spine announced publication of a case series detailing endoscopic transforaminal decompression and fusion with the VariLift-LX system.
Zimmer Biomet Gains 510(k) Clearance for Zyston Strut Open Titanium Interbody Spacer
Zimmer Biomet received FDA 510(k) clearance to market the Zyston® Strut Open Titanium Interbody Spacer, the company's first 3D-printed titanium spinal implant.
Cerapedics Study Results: i-FACTOR Bone Graft in Lumbar Posterolateral Spine
Study results indicate that Cerapedics' i-FACTOR Peptide Enhanced Bone Graft demonstrated a 50% fusion rate in lumbar posterolateral spine surgery patients vs. 20% fusion rate with allograft.
Providence Medical Technology Gains FDA Clearance for DTRAX Spinal System
Providence Medical Technology announced FDA 510(k) clearance to market its DTRAX® system for use in posterior cervical fusion.
Xtant Medical Expands Cervical Portfolio with First Porous Titanium Implant
Xtant Medical received FDA 510(k) clearance for its InTice-C Porous Titanium Cervical Interbody System.
Globus Medical Announces Positive LLIF Study Results
In a study comparing expandable and static LLIF devices, at 2-year follow-up, researchers observed no implant subsidence in patients treated with expandable devices, with 16% subsidence in levels treated with static spacers.
K2M Launches MOJAVE PL 3D Expandable Interbody
K2M commenced full U.S. commercial launch of the MOJAVE PL 3D Expandable Interbody featuring Lamellar 3D Titanium Technology.
Alphatec Announces 1Q18 Revenue
Xtant Medical Posts 1Q18 Revenue
Globus Medical Posts 1Q18 Revenue
K2M Reports 1Q18 Revenue
NuVasive Posts 1Q18 Revenue
UHC’s Bundled Payments Demonstrate Improved Outcomes, Reduced Costs
UnitedHealthcare's Spine and Joint Solution bundled payment program has demonstrated fewer readmissions and complications following surgery and generated ~$18MM in savings for participating employers.
SeaSpine 1Q18 Revenue Grows 4% YoY
Medtronic Launches Advanced SynergyTLIF Workflow for Lumbar Spine Surgery
Medtronic introduced the SynergyTLIFSM workflow to perform a completely navigated MIS spinal procedure in fewer intra-op steps.
Medtronic Launches TiONIC 3D Printed Titanium for Spine Implants
Medtronic launched TiONIC 3D-printed titanium technology for spinal implants.
ChoiceSpine Launches Tiger Shark Porous Interbody Device
ChoiceSpine launched Tiger Shark, a next-gen titanium alloy interbody created with BioBond proprietary porous surface structure.
Meditech Spine Gains Additional FDA Clearance for CURE Lumbar Plate
Meditech Spine received FDA 510(k) clearance for CURE Lumbar Plating iView and QMax, with new sizing options to complement the company's existing CURE system.
Medtronic Gains FDA Approval for INFUSE with Additional PEEK Implants
Medtronic gained FDA approval for use of Infuse bone graft with additional PEEK-based implants in oblique lateral and anterior lumbar interbody fusion procedures at one level.
DePuy Synthes Launches PROTI 360 Interbody Devices
DePuy Synthes commenced U.S. launch of PROTI 360°, interbody fusion systems featuring titanium-integrated PEEK with 360 degrees of titanium integration.
Spineart Achieves Milestone 1,000 Procedures with Juliet Ti-LIFE
Spineart has completed >1,000 procedures in the U.S. utilizing JULIET Ti-LIFE titanium technology.
PediGuard Used in 1st Deformity Surgery in China
SpineGuard announced the first spinal deformity procedure to be performed in China using the PediGuard® device for pedicle screw placement.
Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI
Patrick Sweeney, M.D., is a spine surgeon with a special interest in minimally invasive surgery. He is also Founder and Medical Director of the Center for Minimally Invasive Surgery, an ASC, as well as an inventor/entrepreneur, and founder of a device company and an eHealth entity. We spoke with him about his diverse orthopaedic endeavors.
iOrthopedics Files Additional US Patent Application
iOrthopedics filed another U.S. patent application on the Universally Expanding Cage, protecting its novel design that supports customized reconstructive spinal surgery.
Safe Orthopaedics Reaches Milestone 10,000th Surgical Kit Sale
Safe Orthopaedics marked the sale of >10,000 sterile kits for vertebral surgery worldwide, since launch.
Spineology U.S. Fusion Trial Interim 12-Month Outcomes Data
Initial outcomes from the SCOUT trial of Spineology's OptiMesh® device revealed statistically significant improvements in low back pain and function scores at 6 and 12 months.
Life Spine Posts 1Q18 ProLift Revenue +93% vs. 1Q17
CoreLink’s Full Launch of Foundation 3D-Printed Interbody Cages
CoreLink commenced full commercial release of Foundation 3D interbody cage systems for cervical and lumbar fusion.
iOrthopedics Awarded IP Validation
iOrthopedics was awarded U.S. Patent No. 9,861,494 for a Universally Expanding Spine cage.
Globus Launches ELSA Expandable Lateral Spacers
Globus Medical launched ELSA® AL and ELSA®-ATP lateral expandable interbody spacers with integrated screw fixation.
CTL Gains FDA Approval for Seurat Pedicle Screw
CTL Medical gained FDA 510(k) clearance to market the SEURAT Universal Pedicle Screw. The product is slated for 2H18 launch.
NuVasive Launches ALIF Retractor for Lateral and Supine Surgery
NuVasive launched ALIF Access, its first Maximum Access Surgery ALIF retractor for lateral and supine surgery approaches.
First Implant of Spinal Resources Swedge Pedicle Screw
Spinal Resources announced successful clinical implantation of the first Swedge Pedicle Screw.
NuVasive Porous PEEK Material Impaction Study Results
Studies demonstrated advantages of NuVasive's Porous PEEK interbody fusion devices vs. titanium-coated PEEK in impaction durability.
Nanovis Gains FDA Clearance of FortiCore Interbodies with Nanosurface Technology
Nanovis received FDA 510(k) clearance to market FortiCore® interbody fusion devices that feature a Nanosurface-enhanced porous titanium scaffold, intermolded with a PEEK core.
RTI’s Simmetry Reduces SI Joint Range of Motion
Study results demonstrate that RTI Surgical's Simmetry® Sacroiliac Joint Fusion system provided effective joint fixation, markedly reducing range of motion in the SI joint.
Life Spine Gains FDA Clearance of PLATEAU-LO Insert and Rotate Spacer
Life Spine received FDA 510(k) clearance to market the PLATEAU®-LO Insert and Rotate Spacer system for lumbar interbody fusion.
K2M Launches Next-Gen YUKON OCT System
K2M commenced full launch of the next-generation YUKON OCT posterior fixation system, designed to support cervical sagittal balance in the occipito-cervico-thoracic regions.
CTL Medical Gains FDA Clearance for MATISSE Ti-PEEK ACIF Cage
CTL Medical received FDA 510(k) clearance for the MATISSE Ti-PEEK ACIF cage, featuring TiCro surface technology.
Alphatec Reports 4Q17, 2017 Revenue
Benvenue Medical Luna Interbody Fusion Study Results
Retrospective analysis of Benvenue Medical's Luna® 3D Multi-Expandable Interbody Fusion system indicate that minimally invasive TLIF placement of the device was safe and effective.
Captiva Spine Launches TransFasten SI Fusion and HyperLOX Posterior Cervical System
Captiva Spine announced initial TransFasten Posterior SI Fusion procedures, and launch of the HyperLOX posterior cervical system.
Life Spine Announces First Clinical Use of SENTRY 2 Lateral Plate
Life Spine announced the first clinical use of the SENTRY 2 lateral plate.
Amedica Receives FDA Clearance of Valeo C+CsC
Amedica announced FDA 510(k) clearance of the Valeo C+CsC with Lumen interbody fusion device.
Stryker Gains FDA Clearance for Tritanium TL Curved Posterior Lumbar Cage
Stryker Spine received FDA 510(k) clearance to market Tritanium® TL, a 3D-printed curved posterior lumbar interbody fusion cage. The device will launch in 2Q18.
WishBone Medical to Distribute Implanet’s JAZZ Implants
WishBone Medical entered into a U.S. distribution agreement with Implanet addressing JAZZ spinal implants.
Orthofix Cervical-Stim Device Shown to Improve Fusion Rates
Studies show that use of pulsed electromagnetic field treatment after ACDF significantly increased the fusion rate vs. control at 6 and 12 months, for participants at risk for pseudoarthrosis.
Spineology Receives USPTO Notice for Duo LIF Implant
Spineology received a Notice of Allowance from the USPTO that includes three independent device claims covering the Duo intervertebral implant
SeaSpine Announces 4Q17, 2017 Revenue
NuVasive Posts 4Q17, 2017 Revenue
Implanet and L&K Biomed Finalize Cross-Distribution Agreements
Implanet and L&K Biomed finalized agreements for cross-distribution of spinal products in the U.S., Asia/Oceania and Europe.
Globus Medical Posts 4Q17 and 2017 Revenue
Medtronic Posts FY3Q18 Revenue Growth
Spine Wave Launches Proficient Posterior Cervical Spine Implants
Spine Wave expanded the Proficient® Posterior Cervical Spine system to address complex posterior cervical/thoracic procedures.
Nexxt Spine Milestone: 250 Implantations of NEXXT MATRIXX Interbodies
Nexxt Spine marked the milestone of 250 implantations of its NEXXT MATRIXX® interbody devices.
Spineology Completes Enrollment in Trial of OptiMesh Spinal Fusion Implant
Spineology completed enrollment in the Spineology Clinical Outcomes Trial, investigating use of the OptiMesh® implant in instrumented lumbar interbody fusion.
TranS1 Granted Three New Patents
TranS1 was granted patents addressing presacral interbody fusion technologies, including new expandable cages and a new sacroiliac fusion technique.
Camber Spine Notes First Procedures with SPIRA-C Open Matrix Interbody
Camber Spine announced successful completion of initial surgeries with the SPIRA-C Open Matrix cervical interbody fusion implant.
Emerging Implant Technology Gains FDA Approval for Multilevel Cervical Cage
Emerging Implant Technologies gained expanded FDA clearance to market EIT Cellular Titanium® Cervical Cages for multiple contiguous levels.
Orthofix Gains FDA Clearance for FORZA XP Expandable Spacer
Orthofix received FDA 510(k) clearance to market the FORZA® XP Expandable Spacer for posterior and transforaminal lumbar interbody fusion.
SeaSpine Expands Ventura NanoMetalene Range
SeaSpine expanded the Ventura NanoMetalene® interbody line to include sizes that accommodate a larger range of posterior procedures and more patient anatomies.
Implanet Enters Distribution Agreement with Aegis Spine
Implanet entered into a U.S. distribution agreement with Aegis Spine, subsidiary of L&K Biomed, to complement Implanet's commercialization activity in the region.
Amedica Provides a Business Update
Among its business updates, Amedica announced that the Taurus Pedicle Screw generated ~US $1.3MM in 2017 revenue and was employed in >250 procedures since its 1Q17 launch.
Spine Wave Launches GraftMag Graft Delivery System
Spine Wave launched the GraftMag® bone graft delivery system for thoracolumbar spinal fusion procedures.
Life Spine ProLift Spacer Revenue +493% vs. 2016
4WEB Medical Posts 57% YoY Revenue Growth
Spineology Duo LIF Postmarket Study Update
First study cases are complete in Spineology's postmarket investigation of the Duo Lumbar Interbody Fusion system.
K2M Reports Preliminary 4Q17 and 2017 Revenue
RTI Surgical Acquiring Zyga Technology
RTI Surgical entered into an agreement to acquire Zyga Technology, developer of the SImmetry® Sacroiliac Joint Fusion system.
Zyga Reports Initial Results in SImmetry SI Fusion Study
Initial outcomes from Zyga's EVSI study indicate a significant reduction in low back pain and opioid use in patients receiving the SImmetry® SI Joint Fusion implant.
NuVasive Update on COALESCE, COHERE Interbody Fusion Devices
NuVasive launched COALESCE for Thoracolumbar Interbody Fusion, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion device with expanded indications.
Life Spine Announces Initial Cases with SIMPACT Tri-Fin Sacroiliac Joint Fusion
Initial cases are complete and multiple surgeries performed with Life Spine's SIMPACT™ Tri-Fin Sacroiliac Joint Fusion device, following its November 2017 launch.
K2M Receives CE Mark for CAPRI Cervical 3D Expandable Cage
K2M received approval under the CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage, and announced completion of its first surgical case.
Camber Spine Gains FDA Clearance for Spira-C Open Matrix Cervical Interbody
Camber Spine received FDA 510(k) clearance to market the SPIRA™-C Open Matrix cervical interbody fusion device.
Globus Medical SECURE-C Disc vs. ACDF: 7-Year Follow-up
Results of seven-year clinical trial follow-up indicate superiority of Globus Medical's SECURE-C® cervical disc vs. ACDF in the treatment of cervical disc disease.
First US Procedures for Emerging Implant Technologies Spinal Cages
Emerging Implant Technologies announced completion of first U.S. procedures with its 3D-printed titanium spinal cages.
Xtant Medical Reports 3Q17 Revenue
Medicrea Gains FDA Clearance for 3D-Printed Ti Interbody
Medicrea received FDA 510(k) clearance to market IB3D™ 3D-printed interbody devices, and introduced its AdapTEK™ in-house additive manufacturing technology.
Life Spine Launches SIMPACT TRI-FIN Sacroiliac Joint Fixation Screws
Life Spine commenced limited launch of the SIMPACT™ TRI-FIN sacroiliac joint fixation screw.
Titan Spine’s First Endoskeleton Interbody Fusion Cases in Australia
Titan Spine entered the Australian market with its Endoskeleton® interbody fusion devices and surface technology.
Globus Medical Announces 3Q17 Revenue
Alphatec Spine Posts 3Q17 Revenue
SpineGuard and XinRong Medical Launch PediGuard in China
SpineGuard and XinRong Medical are launching Classic PediGuard® pedicle screw placement tools in China.
SeaSpine Reports 3Q17 Revenue
Amedica Submits FDA 510(k) for Valeo Implant with Lumen
Amedica made a (510)k submission to FDA for its Valeo C+CSC with Lumen cervical spinal implant.
K2M 3Q17 Revenue Growth Up 6% YoY
Zimmer Biomet 3Q17 Orthopaedic Revenue
Pinnacle Spine Files to Market InFill with HA-Enhanced PEEK OPTIMA
Pinnacle Spine expects 4Q17 FDA 510(k) clearance to market InFill® Lateral Lumbar Fusion systems with Invibio's HA Enhanced PEEK-OPTIMA material.
Orthofix 3Q17 Revenue +7% Year Over Year
Stryker’s 3Q17 Orthopaedic Revenue +4% vs. 3Q16
SAGICO Launches Spinal Restoration Technologies
SAGICO commenced North American debut of its expandable interbody fusion system, comprising Aria Lumbar and Arion Cervical devices.
NuVasive 3Q17 Revenue +3.2% vs. 3Q16
Study Indicates Reduced Subsidence with 4WEB’s Lateral Spine Truss
Studies indicate that 4WEB Medical's Lateral Spine Truss demonstrated a better resistance to subsidence vs. an annular interbody implant.
CoorsTek Medical Marks First Human Implantation of New SI Fusion System
CoorsTek Medical announced the first human implantation of Integrity-SI™ Fusion MIS implants, developed in collaboration with the Mayo Clinic.
Initial Surgeries with Expanding Orthopedics’ FLXfit 15 Cage
Expanding Orthopedics announced first surgeries with FLXfit™15, its 3D-expandable cage.
RTI Surgical Launches 3D-Printed Polymer Interbody: Fortilink-C
RTI Surgical launched its first device featuring TETRAfuse® 3D-printed polymer material: the Fortilink®-C IBF system.
Zimmer Biomet Launches Vitality+ and Vital Spinal Fixation in the U.S.
Zimmer Biomet commenced U.S. launch of Vitality®+ and Vital™ spine fixation lines.
GS Solutions Launches AnyPlus DLIF System
GS Medical USA commenced full launch of AnyPlus® for Direct Lateral Interbody Fusion, as well as Anterior and Posterior Disc Prep sets.
DePuy Synthes Launches MIS Spine Surgical Tools
DePuy Synthes launched VIPER PRIME™ and CONCORDE® Clear MIS Discectomy tools for MIS spinal fusion.
ChoiceSpine Receives FDA Clearance for Blackhawk Interbody Fusion Device
ChoiceSpine received FDA 510(k) clearance to market Blackhawk™, an integrated, self-locking anterior cervical fusion device.
Sites Medical and Integrity Implants Enter License Agreement
Sites Medical entered into an agreement to license OsteoSync™ Ti technology to Integrity Implants for its use in expandable interbody devices.
Stryker Launching Serrato Pedicle Screw, Tritanium Cervical Cage
Stryker is fully launching its Serrato™ pedicle screw and Tritanium® C Anterior Cervical Cage devices.
Completion of Initial Spinal Jaxx Surgeries
NeuroPro Spinal Jaxx announced completion of the first commercial surgeries with the Spinal Jaxx expandable lumbar interbody fusion device.
VGI Medical Enters Lateral Spine Market
VGI Medical commenced commercial launch of the VerteLP® Lateral Interbody Fusion system.
K2M Acquires Cervical VBR from Cardinal Spine
K2M acquired Cardinal Spine's cervical static corpectomy cage, to be branded as the PALO ALTO® system.
RTI Surgical Introduces TETRAfuse 3D-Printed Interbody Polymer Material
RTI Surgical introduced TETRAfuse®, reportedly the first 3D-printed polymer implant material to demonstrate trabecular bone ingrowth plus radiolucency and bone-like mechanical properties.
NuVasive Launches New Lateral Procedural Technologies
NuVasive launched Lateral ALIF, XLIF Crestline™ and Lateral MAS® Fixation, expanding its lateral single-position procedure portfolio.
DePuy Synthes 3Q17 Orthopaedic Revenue +0.5% YoY
Spineology Initiates Postmarket Study of Duo Lumbar Interbody Fusion System
Spineology launched a postmarket study to assess patient outcomes with the Duo™ Lumbar Interbody Fusion system.
NuVasive Launches 3D-Printed Modulus XLIF Titanium Implants
NuVasive launched Modulus® XLIF®, 3D-printed titanium implants for use in lateral lumbar interbody fusion.
Implanet Gains CE Mark Approval for JAZZ Passer
Implanet received approval under the CE Mark to market the JAZZ® Passer, used in posterior fixation procedures.
Life Spine Introduces the SENTRY ALIF Plate
Life Spine commenced alpha launch of the SENTRY™ ALIF Plating System, designed to omit the need for posterior stabilization with anterior lumbar interbody fusion.
DePuy Synthes Debuts VIPER PRIME MIS Pedicle Screw
DePuy Synthes unveiled the VIPER PRIME™ pedicle screw. Full EMEA commercial launch is slated for early 2018.
NuVasive Receives Expanded FDA 510(k) Clearance for TLX Interbody System
NuVasive received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 20° cage, use with allogeneic bone graft and use in additional levels of the spine.
4WEB Medical Launches Next-Gen Anterior Spine Truss
4WEB Medical launched its next-generation 3D-printed Anterior Spine Truss interbody fusion system.
Nexxt Spine Gains FDA Clearance for NEXXT MATRIXX Devices
Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices.
Zimmer Biomet Launches Avenue T TLIF Cage with VerteBRIDGE Plating
Zimmer Biomet commenced U.S. launch of the Avenue® T TLIF Cage, featuring self-guided, curved VerteBRIDGE® plating.
Spineology Fully Launches Elite Expandable Interbody Fusion System
Spineology commenced full market release of the Elite™ Expandable Interbody Fusion system. More than 300 cases have been completed since limited launch in 2Q16.
K2M Receives FDA Clearance for YUKON OCT System
K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine.
Wenzel Spine Updates VariLift-C Interbody System
Wenzel Spine commenced U.S. launch of revisions to its VariLift®-C standalone interbody fusion system, including new implant sizes and MIS instrumentation.
Expanding Orthopedics’ FDA Clearance for FLXfit15 3D-Articulated Expandable Cage
Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 expandable interbody cage.
Providence Medical Receives FDA Clearance for ALLY Posterior Fixation
Providence Medical Technology received FDA 510(k) clearance to market the ALLY™ Posterior Fixation system as an adjunct to fusion in the cervical spine.
HD LifeSciences Launches NanoHive Lumbar Interbodies
HD LifeSciences received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.
SeaSpine Launches Shoreline Anterior Cervical Standalone System
SeaSpine commenced full commercial launch of Shoreline®, its anterior cervical standalone system.
Spine Companies $100MM to $2BB: Strategic Activity Update
Highmark Now Covers Zyga SI Fusion System
U.S. insurer Highmark now covers all U.S. FDA-cleared instrumentation for SI joint fusion, including cages or screws, with or without bone graft.
Interim Results in ALLOB Phase IIA Spinal Fusion Study
Interim results in a Phase IIA trial with Bone Therapeutics' ALLOB® show evidence of successful spinal fusion and statistically significant improvements at 12 months.
Xtant Medical Receives FDA Clearance for Expanded Indications of Irix-A
Xtant Medical received FDA 510(k) clearance to market line extensions for the Irix-A standalone interbody spacer.
Implanet Gains FDA Clearance for JAZZ Passer
IMPLANET received FDA 510(k) clearance to market JAZZ™ Passer, a system of spinal instruments and braided band technology.
Spinal Resources’ FDA Clearance of Swedge Pedicle Screw
Spinal Resources received FDA 510(k) clearance to market the Swedge™ Pedicle Screw system.
Medtronic Posts FY1Q18 Revenue Growth
ChoiceSpine Completes 1,000th TOMCAT ACDF
ChoiceSpine completed its 1,000th TOMCAT anterior cervical discectomy and fusion procedure.
EIT Emerging Implant Technologies Acquires 22 Patents for 3D Printed Expandable Cage Technology
Emerging Implant Technologies acquired a portfolio of 22 issued and pending patents covering 3D printed expandable spinal fusion cages.
CoreLink Launches Stackable Guide Wire for Entasis SI Joint Fusion
CoreLink introduced Scaltoff™, a stackable guide wire for the Entasis® Sacroiliac Joint Fusion system.
Life Spine Performs Cases with Multiple Methods of In Situ Expansion
Life Spine announced the first cases performed using multiple methods of in situ expansion with the PROLIFT® Lordotic system and the TiBOW™ Expandable TLIF Spacer.
Stryker Spine Receives FDA 510(k) Clearance for Serrato Pedicle Screw
Stryker Spine received FDA 510(k) clearance to market the Serrato™ Pedicle Screw.
Spine Wave Launches Proficient Posterior Cervical System
Spine Wave commenced limited market release of the Proficient® Posterior Cervical system. Full launch is slated for early 4Q17.
Camber Spine Commences U.S. Launch of SPIRA Open Matrix ALIF
Camber Spine Technologies received FDA 510(k) clearance and commenced U.S. launch of the SPIRA™ Open Matrix ALIF device, manufactured with additive techniques.
Expanding Orthopedics Receives Additional Patents for Interbody Cage Technology
Expanding Orthopedics was granted two additional U.S. Patents covering expandable interbody cage technology.
Renovis Receives FDA Clearance for 3D-Printed PLIF Systems
Renovis Surgical received FDA 510(k) clearance to market Tesera® 3D-printed posterior lumbar interbody fusion systems.
Life Spine’s First Clinical Use of TiBOW MIS TLIF Expandable Spacer
Life Spine announced the first clinical uses of TiBOW™, its minimally invasive expandable TLIF system featuring Osseo-Loc™ surface technology.
K2M 2Q17 Revenue
K2M Acquires Expandable Interbody IP Portfolio
K2M acquired exclusive license to a portfolio of 17 issued and pending patents for expandable interbody technology.
Globus Medical Reports 2Q17 Revenue
SI-BONE Maintains Exclusive Positive Coverage with Blue Cross and Blue Shield
Blue Cross and Blue Shield has updated its coverage policy for MIS SI joint fusion in various states, and maintained an exclusive positive coverage for SI-BONE's iFuse Implant.
Titan Spine Doubles nanoLOCK Surgeon Users
Stryker Reports 2Q17 Revenue
Medicrea Announces First MIS Spine Surgery with Patient-Specific Implants
Medicrea announced completion of the world's first minimally invasive spine procedure using patient-specific implants, with the UNiD™ MIS Rod.
First US Surgeries with 4WEB 3D-Printed Lateral Spine Truss
4WEB Medical announced first surgeries with its Lateral Spine Truss interbody fusion device.
Camber Spine Exceeds 150th Implantation of ENZA Zero-Profile ALIF
Camber Spine Technologies has surpassed 150 implantations of its ENZA™ Zero-Profile ALIF device at one year following launch.
CTL Medical Receives FDA 510(k) Clearance for MATISSE ACIF Cage
CTL Medical received FDA 510(k) clearance to market the MATISSE™ titanium ACIF cage.
Australia Regulatory Approval for Providence Medical’s DTRAX Cervical Fusion Devices
Providence Medical Technology was granted regulatory approval in Australia for DTRAX® cervical fusion devices.
Vertera Spine Receives FDA 510(k) for COALESCE PEEK LIF Device
Vertera Spine received FDA 510(k) clearance to market the COALESCE™ interbody fusion device for ALIF, TLIF, PLIF and LLIF procedures.
Trauma and Spine Markets Gain New FDA Clearances
In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies entering the U.S. market.
DePuy Synthes 2Q17 Orthopaedic Revenue
Premia Spine Launches IDE Study of TOPS Spinal Arthroplasty Device
Premia Spine launched its U.S. pivotal Investigational Device Exemption study of the TOPS™ posterior arthroplasty device vs. traditional lumbar fusion.
Emerging Implant Technologies Receives FDA Clearance for Interbody Devices
Emerging Implant Technologies received FDA 510(k) clearance for 3D-printed spinal interbody devices to address ALIF, PLIF, TLIF and cervical procedures.
Study Results: Inspired Spine’s OLLIF Procedure for Adult Scoliosis
Research indicates that Inspired Spine's OLLIF procedure yielded substantial pain relief and minimal post-op complications in the trestment of adult degenerative scoliosis.
Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices
Strategic orthopaedic-related 510(k)s issued in June 2017 include: Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS); Tranquil Interbody System (Nexus Spine); PHA S1 Spinal System (Phamedica); Total Hip Arthroplasty Device (Responsive Orthopedics/Medtronic); Interbody Fusion System (Spinal Analytics & Geometrical Implant); Channel Cervical Interbody System (Summit Spine); Coalesce Lumbar Interbody Fusion System (Vertera Spine)
SeaSpine Introduces Skipjack Expandable Interbody System
SeaSpine commenced limited launch and announced initial case completion for the Skipjack™ Expandable Interbody System.
K2M Enters Distribution Agreement with Japan Medicalnext
K2M signed a long-term exclusive distribution agreement with Japan Medicalnext.
Xenco Medical Expands ASC CerviKit in the US
Xenco Medical expanded U.S. availability of the ASC CerviKit delivery and storage platform for disposable ACDF systems.
Study Results: Providence Medical’s CAVUX and DTRAX Fusion Technologies
Studies indicate that Providence Medical Technology's tissue-sparing cervical fusion devices, CAVUX® Cervical and DTRAX® Expandable cages, yielded improvements in pain, with radiographic confirmation of fusion.
Full Commercial Launch for SeaSpine’s Mariner Posterior Fixation
SeaSpine commenced full launch of the Mariner® pedicle-based system for posterior spinal fixation.
Regulatory Clearances for K2M’s NILE Proximal Fixation System
K2M received FDA 510(k) clearance and approval under the CE Mark for the NILE® Proximal Fixation system to treat complex spinal deformity.
Life Spine Expands OSSEO-LOC Spinal Implant Portfolio
Life Spine commenced full commercial launch of new OSSEO-LOC™ titanium surface-treated spinal implants, such as ProLift® Expandable PLIF/TLIF and TiBOW™ Expandable TLIF spacers.
Meditech Spine Releases CURE LP System and Talos Spacers in Pre-Packaged Tray
Meditech Spine received FDA 510(k) clearance for its CURE Lumbar Plating System, expected to be packaged as comprehensive solution with Talos.
Spine Wave Enters ALIF Market with Leva AF Commercial Launch
Spine Wave launched Leva® AF, a titanium device for anterior lumbar interbody fusion.
Intellirod Spine Acquires New Financing and IP
Intellirod Spine raised additional equity financing from new and existing investors to support the commercialization of sensor technologies and related lumbar fusion implants.
Spineology Receives FDA Clearance for Rampart One Anterior Lumbar Interbody Fusion System
Spineology enters anterior market with FDA cleared Rampart One Interbody Fusion System.
K2M Launches MOJAVE 3D-Printed Expandable Posterior Lumbar Interbody
K2M announced FDA 510(k) clearance of MOJAVE™ PL, a 3D-printed expandable posterior lumbar interbody system featuring Lamellar 3D Titanium™.
Implanet Launches JAZZ Braid in Europe and U.S.
Implanet launched the JAZZ™ Braid device in the EU and U.S. following regulatory clearance in those regions.
Zyga Receives New Patent Allowances for SImmetry Sacroiliac Joint Fusion System
Zyga Technology announced the issuance of U.S. Patent No. 9,662,124, relating to the design of the SImmetry Decorticator®.
K2M Introduces SAHARA AL Expandable Stabilization
K2M introduced SAHARA™ AL, the company's first expandable interbody product.
Meditech Spine Receives FDA Clearance for Talos Lumbar PEEK Devices
Meditech Spine received FDA 510(k) clearance for Talos® Lumbar PEEK IBF devices enhanced with hydroxyapatite.
Medicrea Announces FDA Clearance of PASS TULIP Top-Loading Spinal Fixation
Medicrea received FDA 510(k) clearance and performed first surgeries with PASS® TULIP top-loading fixation.
SI-BONE Receives FDA Clearance for iFuse-3D
SI-BONE received FDA 510(k) clearance and commenced full U.S. launch of the iFuse-3D™ Implant.
Vertera Spine Receives CMS ICD-10 Code for COHERE Cervical Interbody Fusion Device
CMS issued a new ICD-10 code for a radiolucent porous interbody fusion device, supporting Vertera Spine's COHERE cervical device.
Polyaxial ZIP ISP Technology Available for Out-Licensing
Aurora Spine's proprietary implant locking technology is available for out-licensing or private labeling opportunities.
Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators
Zimmer Biomet is recalling SpF® PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to potential cytotoxicity issues that were found during routine monitoring.
K2M Launches MESA 2 Cricket Instrumentation
K2M launched MESA 2 Cricket™ instrumentation, an enhancement to the MESA® 2 pedicle screw system.
Medtronic Reports FY4Q17 Revenue
Life Spine Fully Launches PROLIFT Lordotic Expandable Interbody System
Life Spine commenced full commercial launch of the PROLIFT® Lordotic expandable interbody system with OSSEO-LOC™ surface treatment.
Xtant Medical 1Q17 Revenue
Vertebral Technologies Granted Patent for Modular Device Design
Vertebral Technologies received notice of allowance for its patent, "Methods and Apparatus for Minimally Invasive Modular Interbody Fusion Devices."
Providence Medical Technology Secures New $10.5MM Financing
Life Spine’s 510(k) Clearance of CRANIAL FUSION System with SOLSTICE Screws
Life Spine received FDA 510(k) clearance of its CRANIAL FUSION system, expanding indications for use of SOLSTICE Polyaxial Screws into the cervical spine.
SeaSpine Posts 1Q17 Revenue
Inspired Spine Presents OLLIF Procedure Study Results
Results from a 124-patient study indicate that Inspired Spine's OLLIF procedure was completed at ~2x the speed of an open TLIF, and reduced blood loss by >80% vs. TLIF.
iFuse SI Fusion Implant Covered by TRICARE
TRICARE, a managed healthcare program for active duty and retired members of the U.S. military, established a written coverage policy for minimally invasive SI joint fusion such as is provided with SI-BONE's iFuse™ implant.
Premia Spine Secures FDA Approval for IDE Study of TOPS
Premia Spine secured FDA approval for a pivotal IDE study of TOPS™, a posterior arthroplasty device for the treatment of spondylolisthesis and spinal stenosis. The study seeks to establish the superiority of TOPS vs. traditional lumbar spinal fusion.
Medikon to Distribute InterFuse in Turkey
Vertebral Technologies partnered with Medikon for distribution of InterFuse® spinal fusion products in Turkey.
Globus Medical Reports 1Q17 Revenue
Medtronic to Update Labeling for NavLock Tracker
Medtronic issued a Safety Notice related to use of non-Medtronic instruments with the NavLock™ Tracker, an accessory to its StealthStation Surgical Navigation system.
Implanet Receives CE Mark Approval for JAZZ Standalone Implant
Implanet received approval under the CE Mark for the JAZZ™ Standalone implant for posterior spinal fixation.
K2M Posts 1Q17 Revenue, Announces Product Approvals in Japan
K2M posted 1Q17 revenue of US $61.9MM, +9.9% vs. 1Q16. (U.S. $46.2MM, +9.5%; ex-U.S. $15.7MM, +11.1%) Following 1Q, the company received key product registrations from Japan's Pharmaceuticals and Medical Devices Agency, and can now implement a new distribution strategy in that region.
Innovasis Receives FDA 510(k) for Ax Standalone ALIF System
Innovasis received FDA 510(k) clearance to market Ax™, a standalone system for anterior lumbar interbody fusion.
NuVasive Reports 1Q17 Revenue Growth of +16.2% vs. 1Q16
Amedica: Regulatory Clearance for Valeo in Australia
Amedica has been granted marketing clearance in Australia for Valeo® interbody fusion devices.
SI-BONE 6-year Clinical Results of iFuse Implant System
Six-year study results on the treatment of SI joint disorders indicated that treatment with conservative management or radiofrequency denervation led to worsened outcomes, while iFuse Implant patients demonstrated superior improvements.
Amendia Acquired Spinal Elements
Amendia acquired Spinal Elements, provider of implants, instruments and orthobiologics. Terms were not disclosed.
Zyga EVoluSIon Study Enrolls 100th Patient
Zyga Technology enrolled the 100th patient in the EVoluSIon trial investigating long-term results and pain reduction following the SImmetry® Sacroiliac Joint Fusion procedure.
United Orthopedic Acquires A-Spine, Expanding Sales in China
United Orthopedic acquired A-Spine Asia, developer of spinal fixation, osteoplasty and vertebral body replacement systems, for US $20.0MM. For 2016, A-Spine posted revenue of $11.3MM.
24-month CT Fusion and Clinical Results for SImmetry SI Joint Fusion
Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion indicate radiographically-evident fusion as early as 12 months, and increased fusion rates at 24 months.
Safe Orthopaedics Expands Product Availability in Paris
Safe Orthopaedics' products for thoracolumbar spinal fusion have been listed for availability to ~1/4 of the France market.
Inspired Spine Reaches 500 OLLIF Procedure Milestone
Inspired Spine reached the milestone of 500 Oblique Lateral Lumbar Interbody Fusion procedures completed.
Aurora Spine Issued U.S. Patent for Polyaxial ZIP
Aurora Spine was issued U.S. Patent No. 9,603,637, "Polyaxial Interspinous Fusion Implant and Bone Growth Stimulation System."
K2M and LifeHealthcare Distribution Agreement
K2M and LifeHealthcare entered into a new 5-year distribution agreement for K2M's spinal technologies in Australia and New Zealand.
Alphatec Spine Launches Battalion Lateral System with Squadron Retractor
Alphatec Spine launched and completed initial procedures with the Battalion™ Lateral System and Squadron™ Lateral Retractor.
NICE Recommendation for MIS SI Joint Fusion Surgery
The U.K.'s National Institute for Health and Care Excellence published guidance recommending availability of minimally invasive sacroiliac joint fusion surgery to treat chronic sacroiliac pain.
Aesculap Launches Warranty for Plasmapore XP
Aesculap Implant Systems established a warranty program for its Plasmapore®XP-coated spinal interbody fusion devices, and launched the TSpace®XP interbody system.
SI-BONE Milestone: 25,000 iFuse Procedures Performed Worldwide
SI-BONE's iFuse Implant System® for SI joint fusion has been used in >25,000 procedures worldwide.
CoRoent Small Interbody Cleared for Cervical Disc Degeneration at up to 4 Levels
NuVasive received FDA 510(k) clearance to market the CoRoent® Small Interbody™ System for intervertebral body fusion at multiple contiguous levels in the cervical spine.
Providence Medical’s Recent FDA 510(k) Clearances
Providence Medical Technology received FDA 510(k) clearance for ALLY™ Facet Screws and for standalone use of the CAVUX™ Cervical Cage-L system.
Burst Biologics Spinal Fusion Study
Burst Biologics received IRB approval for a U.S. prospective clinical study of BioBurst cellular allograft in spinal fusion.
Alphatec Announces $18.9 Million Private Placement
Alphatec Spine entered into a definitive securities purchase agreement to raise ~US $18.9MM in a private placement.
Initial Procedures with Lucent XP Expandable Interbody Implant
Spinal Elements announced successful completion of initial procedures using the Lucent® XP expandable interbody device.
New Evidence-Based Recommendation for Lateral Interbody Fusion in UK
NuVasive announced updated guidance from the National Industry for Clinical Excellence in the U.K. for lateral lumbar interbody fusion.
Implanet Enters Exclusive Distribution Partnerships in Australia and New Zealand
Implanet announced integration of its Jazz Claw device into the Australian Register of Therapeutic Goods and entry into an exclusive partnership with Device Technologies for product distribution in Australia and New Zealand.
First Implantation of Spine Innovation Expandable Interbody Fusion Cage
Spine Innovation announced first implantations of its Expandable TLIF device.
Broader FDA Clearance for Spineology Elite Expandable Interbody Fusion System
Spineology received expanded FDA 510(k) clearance of the Elite Expandable Interbody Fusion system, to include a narrower 10mm version of the device and an indication for use with allograft bone.
Study Results: Vitrium Bioactive Glass in Ovine Spinal Fusion
Results from ovine study of Bio2 Technologies' Vitrium bioactive glass demonstrated the device's capability to support interbody fusion.
Three New Ex-U.S. Distribution Partners for VTI
Vertebral Technologies appointed new distributors in Finland, Germany and Sweden to expand access to InterFuse® modular interbody fusion implants.
Limited U.S. Launch of Arsenal Deformity Adolescent Scoliosis System
Alphatec Spine commenced limited U.S. launch of the Arsenal™ Deformity Adolescent Idiopathic Scoliosis system.
joimax Obtains Full Product Registration in Thailand
joimax obtained full product registration from the Thai Food & Drug Administration. Certification in Japan, Malaysia and Taiwan is expected during 2017.
Wenzel Spine Acquires PrimaLOK SP & FF Platforms from OsteoMed
Wenzel Spine acquired PrimaLOK™ SP Interspinous Fusion and PrimaLOK™ FF Facet Fixation systems from OsteoMed.
GS Medical USA Announces New Product Portfolio
GS Medical USA is launching AnyPlus® ACIF and the AnyPlus® Dual-Lead Pedicle Screw system in March 2017, to be followed by the AnyPlus® DLIF implant in 2Q17.
Nanovis Launches FortiCore PLIF
Nanovis completed alpha launch of FortiCore® PLIF, featuring a deeply-porous titanium scaffold with a PEEK core, and announced implantation of the 2,000th FortiCore implant.
DePuy Synthes Launches ViviGen Formable Cellular Bone Matrix
DePuy Synthes and LifeNet launched ViviGen Formable™ Cellular Bone Matrix, next-gen allograft to support bone formation during spinal fusion.
Strategic orthopaedic-related 510(k)s issued in January 2017
Strategic orthopaedic-related 510(k)s issued in January 2017 include: Fibulink Syndesmosis Repair Kit (Akros Medical), Anatomic Total Knee (Amplitude), Facilis Pedicle Screw System (Baui Biotech), GEO Bone Screw (Gramercy Extremity Orthopedics), Roccia ACIF Intervertebral Fusion System (Silony Medical), Fitbone TAA Intramedullary Lengthening System (Wittenstein Intens)
ChoiceSpine Launches Harrier ALIF System
ChoiceSpine launched HARRIER™, a PEEK-based anterior lumbar interbody fusion system.
Vertebral Technologies Enters GPO Contract
Vertebral Technologies entered into a GPO contract to provide modular interbody fusion devices to member facilities of Resource Optimization & Innovation/ROi.
Third FDA Clearance for Minuteman G3-R Implant
Spinal Simplicity received its third FDA 510(k) clearance for the Minuteman G3-R spinal implant.
SpineSource to Market Kisco’s L-Varlock Expandable Lumbar Cage
SpineSource entered into a long-term exclusive U.S. agreement to distribute Kisco International's L-Varlock® Expandable Lumbar Cage for vertebral interbody fusion.
Full Launch of SeaSpine’s Vu aPOD Prime NanoMetalene System
SeaSpine commenced full commercial launch of the Vu aPOD™ Prime NanoMetalene System for anterior lumbar interbody fusion.
DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screws
DePuy Synthes received FDA 510(k) clearance to market VIPER® and EXPEDIUM® Fenestrated Screw systems for use with cement to restore spinal column integrity in the treatment of advanced stage tumors.
Camber Spine FDA 510(k) Clearance for Siconus SI Joint Fixation
Camber Spine Technologies received FDA 510(k) clearance for the Siconus™ SI Joint Fixation System for the treatment of sacroiliac disease.
Study Results: iFuse vs. SI Joint Fixation with Screws
Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion patients receiving SI-BONE's iFuse™ vs. a 30.8% revision rate for those undergoing screw fixation.
Precision Spine Receives FDA 510(k) Clearance for ShurFit ACIF 2C System
Precision Spine received FDA 510(k) clearance of its ShurFit® ACIF 2C Anterior Cervical Interbody System, featuring a titanium + hydroxyapatite coating to support bone growth.
Retrospective Study: Spinal Elements’ Magnum+ ALIF Device With Ti-Bond Coating
Patients in a retrospective study of Spinal Elements' Magnum+® ALIF device with Ti-Bond® coating demonstrated a 96% success rate, with subjects achieving solid arthrodesis at an average of 7.3 ± 2.3 months.
Aurora Spine Issued U.S. Patent Related to Polyaxial ZIP Technology
Aurora Spine announced the allowance of U.S. Patent Application No. 14/732,240, "Polyaxial Interspinous Fusion Implant and Bone Growth Stimulation System.”
First Successful Spinal Implant in Mexico using VTi’s Interfuse
Vertebral Technologies announced a successful outcome in the first lumbar fusion procedure in Mexico using the InterFuse® laterally-expandable device.
Spinal Simplicity: Six New Patents Granted in 2016
Six new patents were granted to Spinal Simplicity in 2016, bringing its portfolio to 52 globally. A new Notice of Allowance in 2017 brings the company's U.S. patent total to 16.
Strategic orthopaedic-related 510(k)s issued in December 2016
Strategic orthopaedic-related 510(k)s issued in December 2016 include: Envision 3D Image Guidance System (7D Surgical); Sphynx Anterolateral Plate (Eden Spine); Destiknee Total Knee (Meril Healthcare); Hubble II Lumbar Interbody Fusion System (Orbbo Surgical)
Amedica’s First Taurus Pedicle Screw System Surgery
Amedica announced successful completion of the first surgery using the Taurus™ Pedicle Screw.
Medicrea Submits 510(k) for 3D-Printed Titanium Spinal Interbody Devices
Medicrea filed its FDA 510(k) submission for 3D-printed titanium interbody devices with compatible UNiD™ Lab surgical planning and analytical services.
Globus Medical Receives CE Mark for Excelsius GPS
Globus Medical received CE Mark approval for the Excelsius GPS™ robotic trajectory guidance and navigation system.
EU Patent for JAZZ Implant Universal Tensioning System
Implanet was granted a European patent for the JAZZ® implant universal tensioning system.
DePuy Synthes Acquires Interventional Spine Expandable Cage Technology
DePuy Synthes entered into an asset purchase and development agreement with Interventional Spine, addressing expandable fusion cages and a facet screw system for open and percutaneous spine surgery.
NuVasive to Resume XLIF Procedures in Japan in 1Q17
NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure.
Precision Spine Receives FDA 510(k) Clearance for AccuFit Lateral Plate
Precision Spine received FDA 510(k) clearance for the AccuFit® Lateral Plating System.
12-month Clinical and Radiographic Results with SImmetry Sacroiliac Joint Fusion
Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion procedure indicate that, at 12 months, fusion was reported in 88% of patients and back pain decreased by 46%.
New Indication for RTI Surgical’s C-Plus Peek IBF System
RTI Surgical's C-Plus™ PEEK Interbody Fusion system is now indicated for use with allograft, including the company's map3® cellular allogeneic bone graft.
MEDICREA’s 1,000 Patient-Specific UNiD Rod Procedure Milestone
Medicrea's patient-specific UNiD™ Rod technology has now been used in >1,000 procedures in Europe and the U.S.
Xtant Medical Receives FDA Clearance for Xsert Lumbar Expandable Interbody System
Xtant Medical announced FDA 510(k) clearance to market the Xsert™ Lumbar Expandable Interbody System. Initial product launch will commence in mid-2017.
Amedica Provides Regulatory Updates: Taurus and Valeo
Amedica's Taurus pedicle screw system has received FDA 510(k) clearance for marketing. First implantation and full market launch are slated to occur by year-end.
CMS Publishes 2017 Final Rule Increasing Outpatient Facility Reimbursement for MIS SI Joint Fusion
CMS issued its 2017 Final Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center payment rule for MIS sacroiliac joint fusion. New payments are effective January 2017.
DePuy Synthes Spine Introduces Zero-Profile Plate with Allograft Spacer
DePuy Synthes Spine launched the ZERO-P NATURAL™ Plate, designed for use with the CC Natural allograft spacer, for spinal fusion procedures in the neck.
Pre-clinical Study Results: Stryker’s 3D-printed Tritanium PL Interbody Cage
Results from a pre-clinical interbody fusion study of Stryker Spine's 3D-printed Tritanium PL Interbody Cage demonstrated statistically superior range of motion, bone in-growth and greater average construct stiffness vs. PEEK and titanium plasma-sprayed PEEK cages.
4WEB Medical Announces First U.S. Surgeries with Curved TLIF Device
4WEB Medical announced completion of first surgeries using the Curved Posterior Spine Truss system for TLIF procedures.
DePuy Synthes Launches SYNFIX Evolution for ALIF
DePuy Synthes Spine launched SYNFIX® Evolution for standalone Anterior Lumbar Interbody Fusion (ALIF).
Spineology Completes 100 Cases with Palisade Pedicular Fixation System
Spineology announced completion of 100 cases using the Palisade™ Pedicular Fixation System.
SeaSpine Receives FDA 510(k) Clearance for Shoreline ACS System
SeaSpine received FDA 510(k) clearance to market the Shoreline™ ACS Anterior Cervical Standalone system. Full commercial launch is slated for 1H17.
Medicrea Launches Lifetime Warranty for Patient-Specific UNiD Constructs
Medicrea will implement a lifetime warranty on its patient-specific UNiD™ technology implanted in the U.S. from 11/1/16.
Globus Medical Launched the QUARTEX™OCT Stabilization System and the INDEPENDENCE MIS™ integrated ALIF plate/spacer
Globus Medical launched the QUARTEX™ OCT Stabilization System and the INDEPENDENCE MIS™ integrated ALIF plate/spacer.
Tyber Medical Launches TyPEEK Lateral Implant
Tyber Medical commenced full launch of their lateral access, next-gen lateral PEEK/titanium composite interbody and lateral plating systems.
RTI Surgical Receives Additional 510(k) Clearance for Streamline OCT System
RTI Surgical received an expanded FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System, including an indication for polyaxial screw placement in the cervical spine, and also clearance for a dual diameter transition rod.
KB Medical Closes Series B Financing
KB Medical raised CHF 2.5MM (~US $2.51MM) in a Series B Financing. Funds will support FDA clearance for the AQrate™ Robotic Assistance System V 1.2 for spinal surgery.
Pinnacle Spine Launches InFill® V2 Lateral Interbody Device for Lumbar Spinal Fusion
Pinnacle Spine launched the InFill® V2 Lateral Interbody Device, featuring a large, single graft chamber and a large load-bearing surface area.
Genesys Spine to Debut TiLock Cortical Spinal System
Genesys Spine is launching the TiLock Cortical Spinal System to provide an anatomy-conserving alternative to traditional pedicular fixation.
Ascential Product and Service Offering to Launch
Ascential is launching to offer an implant and delivery solution for lower acuity spinal procedures in ambulatory surgery center and hospital settings. Implants are manufactured by Stryker.
Spineology Receives FDA Clearance of Rampart Duo Interbody Fusion System
Spineology received FDA 510(k) clearance to market the Rampart™ Duo™ Interbody Fusion System, reportedly the first device to combine PEEK, titanium and graft containment mesh elements.
DeGen Medical Launches Latitude-C Porous Ti Cervical Interbody Spacer
DeGen Medical introduced the Latitude-C™ Porous Ti Cervical Interbody Spacer.
Spine Wave Launches Velocity P Expandable Interbody Device
Spine Wave will commence full launch of the Velocity® P Expandable Interbody Device system in mid-November.
Initial Procedures with Spinal Elements’ Katana MIS Lateral System
Spinal Elements announced initial procedures using Katana™, its minimally invasive lateral system.
Early Outcomes with Porous PEEK COHERE Fusion Device
Vertera Spine announced initial successful outcomes using the COHERE® Cervical Interbody Fusion device.
12-month Fusion and Clinical Results with SImmetry Sacroiliac Joint Fusion
Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion with decortication procedure indicated fusion in 74% of patients, at 12 months.
Spineology Completes Limited Launch of Elite Expandable Interbody Fusion System
Spineology successfully completed limited launch of the Elite™ Expandable Interbody Fusion System.
Full U.S. Launch of New nanoLOCK Surface Technology from Titan Spine
Titan Spine commenced full U.S. distribution of Endoskeleton® titanium spinal interbody fusion implants featuring proprietary nanoLOCK® surface technology.
Titan Spine Raises $7.5 Million
Titan Spine raised US $7.5MM in Series D financing to support commercialization of nanoLOCK surface interbody devices.
FDA Clearance for Allograft Bone with Spineology Rampart Interbody Fusion Devices
Spineology received FDA 510(k) clearance for use of allograft bone with Rampart™ Interbody Fusion Devices.
Amedica Awarded New U.S. Patent
Amedica was awarded U.S. Patent No. 9,399,309 for threading sinterable materials, covering methods used for spinal fusion or other biomedical implants.
K2M Expands 3D-Printed MIS CASCADIA Lateral Interbody System
K2M received FDA 510(k) clearance for additional implant sizes of its CASCADIA™ Lateral Interbody System.
Positive Efficacy Data from ALLOB Phase IIA Spinal Fusion Trial
Bone Therapeutics reported positive efficacy data from its Phase IIA trial of ALLOB® in spinal fusion.
Phygen Receives Notice of Allowance on AutoLok Fixation Screw Assembly in U.S.
Phygen received a Notice of Allowance for the Leucadia AutoLok Fixation Screw Assembly under U.S. Patent Application No. 13/274,243.
Cerapedics Closes $11 Million Series D Financing
Cerapedics completed a US $11MM Series D financing to support expanded commercialization of i-FACTOR™ Peptide Enhanced Bone Graft.
Spineology Launches TLIF Insertion Options for Posterior Midline Approach ACT MediaLIF
Spineology launched a range of TLIF technologies for use with the Anatomy-Conserving Medial Lumbar Interbody Fusion platform (ACT MediaLIF™). These technologies support TLIF placement of interbody devices using a direct posterior approach.
Amendia Launches Syzygy™ Stabilization System
Amendia launched the Syzygy™ Stabilization System, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion.
ulrich medical USA Launches uCerv Titanium Cervical Interbody System
ulrich medical USA commenced U.S. launch of the uCerv® titanium spinal implant, an adjunct to its PEEK-based uCerv system for ACDF procedures.
Study Results from Inspired Spine’s MIS Direct Thoracic Interbody Fusion Procedure
Study results indicate that the minimally invasive direct thoracic interbody fusion or MIS-DTIF approach, offered by Inspired Spine, was shown to alleviate back pain in patients with degenerative disc disease or herniation.
Meditech Spine Receives FDA Clearance for CURE Anterior Cervical Plate
Meditech Spine received FDA 510(k) clearance to market CURE Anterior Cervical Plates to complement its Talos®-C (HA) interbody devices.
VTI Partners with Distributor in Mexico
Vertebral Technologies entered into a strategic partnership with BioMedical Technologies International to distribute InterFuse S™ and T™ spinal fusion devices throughout Mexico.
Globus Medical Completes Acquisition of Alphatec’s International Business
Globus Medical completed its acquisition of the international operations and distribution channels of Alphatec Spine for US $80.0MM in cash.
Life Spine Completes Initial Cases with SENTRY Lateral Plate
Life Spine announced successful completion of initial cases using the SENTRY™ Lateral Plate. Full launch will occur by the end of 2016.
Tyber Medical Launches a Lateral Plate
Tyber Medical commenced commercial launch of a low profile lateral plating system.
2-Year Results from SI-BONE iFuse INSITE Trial
Two-year results from a randomized, controlled trial in the management of sacroiliac joint dysfunction revealed that SI-BONE's iFuse yielded more rapid improvements in pain, disability and quality of life vs. non-surgical treatment.
FDA Clearance for New Sizes of Amedica’s Valeo II LLIF Device
Amedica received FDA 510(k) clearance for expanded sizes of the Valeo® II Lateral Lumbar interbody fusion device.
SeaSpine to Acquire NLT Spine, Expandable Interbody Platform Technologies
SeaSpine entered into a definitive agreement to acquire NLT Spine, developer of minimally invasive surgery devices. SeaSpine's commercial launch of the first NLT product is expected in 1H17.
Spinal Simplicity Introduces Next-Gen Minuteman G3 with HA Coating
Spinal Simplicity introduced a new generation version of the Minuteman G3 fusion device featuring an FDA-cleared hydroxyapatite coating.
Titan Spine Expands Distribution of Endoskeleton to Italy
Titan Spine expanded its agreement with MBA to include distribution of Endoskeleton® titanium implants in Italy.
Medtronic Completes $20MM Second Tranche Investment in Mazor Robotics
Medtronic completed the second tranche of equity investment in Mazor Robotics, as laid out in a previously-executed agreement.
Spine Wave Launches Velocity L Expandable Interbody Device and Enhanced Lateral System
Spine Wave introduced the Velocity™ L Expandable Interbody Device and next-generation lateral access technology.
Medicrea’s €20MM Financing to Support Patient-Specific UNiD Rods
Medicrea entered into agreements to raise €20MM (~US $22.4MM) to support commercialization of UNiD™ Patient-Specific Rods in the U.S. and new ex-U.S. markets.
Strategic Orthopaedic-related 510(k)s issued in July 2016
Strategic orthopaedic-related 510(k)s issued in July 2016 include: Integra External Fixation System (Ascension Orthopedics/Integra); CorticaLink Spinal Fusion Platform (FacetLink dba LinkSpine); Lumbar Interbody Fusion Device (Keos*); MectALIF Anterior Standalone Intervertebral Fusion Device (Medacta); Cure Anterior Cervical Plate (Meditech Spine); Cannulated Screw (Miami Device Solutions); Belvedere Lateral Plating System (NeuroStructures); NEO Arthroscope (Prosurg)
Spinal Elements Ti-Bond Implant Milestone and Warranty Program
Spinal Elements marked the milestone of >10,000 Ti-Bond interbody devices implanted and announced a 1-year warranty for Ti-Bond devices.
1,000th Case Using Vertical Spine’s FIBRINET Technology in Spinal Fusion
Vertical Spine achieved a milestone with the 1,000th case performed using its FIBRINET® System for the generation of Platelet-Rich Fibrin Membrane graft.
Orthofix Launches PHOENIX Minimally Invasive Spinal Fixation in Japan
Orthofix launched the PHOENIX® Minimally Invasive Spinal Fixation system in Japan.
Study Results: Trinity Evolution Allograft in Anterior Cervical Discectomy & Fusion
Data from a 12-month study of 1-level ACDF patients treated with Trinity Evolution® + a PEEK interbody spacer demonstrated fusion rates of 78.6% at 6 months and 93.5% at one year.
4WEB Medical Receives FDA Clearance of Lateral Spine Truss
4WEB Medical received FDA 510(k) clearance to market its Lateral Spine Truss interbody fusion device.
Ortho Kinematics Launches VMA-Align Diagnostic Module to Support Patient Selection
Ortho Kinematics launched VMA-Align, a diagnostic module that provides detailed spinal alignment measurements within the Vertebral Motion Analysis (VMA) product. The data is intended to assist in patient selection and planning for lumbar fusion.
Intellirod Spine Raises Over $1MM
Intellirod Spine raised >US $1.0MM in additional equity financing. Funds will be used to reach key milestones toward commercialization of sensor technologies and lumbar fusion implants.
Medtronic, Zimmer Biomet Enter 2-level Disc and Robotic Markets
Since mid-May, both Medtronic and Zimmer Biomet have announced strategic moves in the 2-level cervical disc replacement and robotic surgery markets. In efforts to invigorate revenue growth, the two have focused on niche technologies that should expand their portfolios-but have yet to prove wide scale.
NeuroPro Spinal Jaxx Receives FDA Clearance for Spinal Fusion Device
NeuroPro Spinal Jaxx received FDA 510(k) clearance to market the Spinal Jaxx expandable intervertebral spacer.
Zimmer Biomet to Acquire Medtech Surgical Robotics Company
Zimmer Biomet announced its plans to acquire Medtech, provider of surgical systems including the ROSA™ Spine robotic-assistive device for minimally invasive surgery.
First Implantation of Camber Spine’s Enza Zero-Profile ALIF Device
Camber Spine Technologies announced the first implantation of the ENZA™ MIS Zero-Profile ALIF device, occuring in a 2-level lumbar procedure.
Benvenue Announces 500th Spinal Fusion with Luna® 3D Interbody Fusion System
Benvenue Medical announced that >500 patients have been treated to date with the Luna® 3D Interbody Fusion System.
Amendia Launches Ceres™ Midline Cervical Plate
Amendia launched the Ceres™ Midline Cervical Plate, intended for anterior screw fixation of the cervical spine as an adjunct to fusion. The system designed for one and two-level surgeries and is available in 18 different length sizes.
Regulatory Clearance in Australia for Centinel Spine’s STALIF L
Centinel Spine received regulatory clearance in Australia for the STALIF L™ No-Profile, Lateral Lumbar Integrated Interbody system.
Initial Cases Complete with Life Spine’s LONGBOW Expandable Lateral Spacer
Life Spine announced successful completion of initial cases with LONGBOW™, the Expandable Lateral Spacer.
Aurora Spine Issued U.S. Patent Related to ZIP MIS Devices
Aurora Spine was issued U.S. Patent No. 9,364,264, "Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System," covering ZIP® devices including ZIP Ultra®, ZIP 51™, ZIP LP™, Dyna-ZIP™, etc.
Centinel Spine Completes Successful Evaluation of STALIF L
Centinel Spine completed the alpha release and commenced U.S. launch of STALIF L™ No-Profile, a lateral lumbar integrated interbody device.
Spinal Elements Receives FDA 510(k) Clearance for Expandable Interbody Device
Spinal Elements received FDA 510(k) clearance to market a line of expandable interbody fusion devices for posterior, anterior and lateral access to the lumbar spine.
Full Launch of Exactech’s Acapella One Cervical Spacer
Exactech commenced full launch of the Acapella® One Spacer, a cervical cage pre-assembled with integrated anchors to prevent device migration during anterior cervical fusion.
SI-BONE Closes $20MM Round of Growth Financing
SI-BONE closed a US $20MM round of growth capital financing. Proceeds will support U.S. sales expansion and R&D to develop new products to treat the SI joint.
Spineology Launches Elite Expandable Interbody Fusion System
Spineology released the Elite™ Expandable Interbody Fusion system, designed to be implanted at a minimal height and expanded after final positioning in the disc space.
Amendia Launches Ceres-C Standalone Cervical Interbody Device
Amendia commenced commercial launch of Ceres™-C, a low-profile standalone PEEK cervical interbody spacer designed for use in ACIF.
SeaSpine Introduces Hollywood VI NanoMetalene Interbody Device
SeaSpine commenced full commercial launch of the Hollywood™ VI (variable insertion) NanoMetalene® device for transforaminal lumbar interbody fusion.
Strategic Orthopaedic-related 510(k)s issued in May 2016
Strategic orthopaedic-related 510(k)s issued in May 2016 include: Navio Indication for TKA (Blue Belt Technologies), Enza Zero-profile Anterior Interbody Fusion System (Camber Spine), CSR Shoulder System (Catalyst OrthoScience*), Stropp/Single Tunnel Repair of Plantar Plate (CrossRoads Extremity), Cervical Interbody Fusion System (Evolution Spine*), Flip Button Suture Anchor (First Ray), Neofuse HA Enhanced PLIF/TLIF (HT Medical*), HC Spinal System (Hung Chun Bio-S*)
SI-BONE Receives 510(k) Clearance on Updated Indication for iFuse Implant
SI-BONE received FDA 510(k) clearance of a modified indication for the iFuse Implant System®, noting that clinical studies have demonstrated its ability to improve pain, patient function and quality of life.
Amedica Submits Response to FDA for Clearance of Composite Interbody Spinal Device
Amedica submitted its responses to FDA in relation to the CASCADE clinical trial, and expects a final determination from FDA within 60 days.
Xtant Medical, Pinnacle Spine Distribution Agreement
Xtant Medical and Pinnacle Spine entered into a joint agreement to expand distribution of Pinnacle's InFill® Lateral Lumbar Interbody Fusion system.
Zimmer Biomet Acquiring LDR
Zimmer Biomet entered into a definitive agreement to acquire LDR for US $37/share in cash, for a transaction valued at ~$1.0BB with an expected 3Q16 close.
First Implantations of Vertera Spine Porous PEEK COHERE Cervical Fusion Device
Vertera Spine announced first implantations with the COHERE™ Cervical Interbody Fusion system. Full market launch is expected in coming months.
Life Spine’s Initial Cases and Multiple Surgeries with PLATEAU-Ti Spacer
Life Spine announced successful completion of initial cases with the PLATEAU®-Ti Spacer, a titanium interbody system featuring OSSEO-LOC™ surface treatment to support potential bone growth.
Pinnacle Spine Launches InFill ALIF
Pinnacle Spine launched the InFill® Anterior Lumbar Interbody Fusion device, compatible with the InFill Graft Delivery System.
K2M Receives FDA Clearance for CASCADIA Cervical, AN Lordotic Oblique Interbody Systems
K2M received FDA 510(k) clearances to market CASCADIA™ Cervical and CASCADIA AN Lordotic Oblique Interbody systems, featuring Lamellar 3D-printed Titanium Technology™.
Centinel Spine Expands MIDLINE II-Ti in U.S. and Australia
Centinel Spine expanded its MIDLINE II-Ti product family, a Ti-ACTIVE™ coated, No-Profile, anterior lumbar Integrated Interbody device, in the U.S. and Australia.
Interventional Spine Announces FDA Clearance of Lordotic Opticage™
Interventional Spine announced FDA clearance of the 80 Lumbar Lordotic Opticage™, an intervertebral body fusion device for use with autogenous bone graft in patients with degenerative disc disease.
Medtronic Announces U.S. Launch of Spine Essentials
Medtronic commenced U.S. launch of Spine Essentials™, implants and instruments designed to lend efficiency to the most common cervical fusion procedures.
Orthofix Announces FDA Clearance, Limited Launch of FORZA PTC Interbody Spacer
Orthofix announced FDA 510(k) clearance and U.S. limited launch of the FORZA® PTC™ (Peek Titanium Composite) Spacer.
Initial Cases Performed with Life Spine PROLIFT Expandable Interbody System
Life Spine announced successful completion of initial cases with the PROLIFT® Expandable Interbody System for minimally invasive PLIF, TLIF and oblique approaches.
Camber Spine Receives FDA Clearance for ENZA Zero Profile ALIF Device
Camber Spine Technologies received FDA 510(k) clearance to market the ENZA™ Zero Profile Anterior Interbody Fusion system.
MEDTECH Announces First U.S. ROSA Spine Surgery
MEDTECH announced the first procedure using the ROSA™ Spine robot in the U.S.
SI-BONE’s iFuse Surpasses 20,000 Surgeries
Since launch in 2009, SI-BONE's iFuse Implant System® has been used in >20,000 procedures worldwide. The product was recently launched in Australia and New Zealand.
Spinal Simplicity Gains Investor Support from Nueterra
Spinal Simplicity closed a financing round with an investment from Nueterra Capital. Funds will support U.S. launch of the Minuteman fusion device to treat low back pain.
Wenzel Spine Launches VariLift-LX
Wenzel Spine commenced full U.S. launch of the VariLift®-LX expandable standalone interbody fusion device.
Intelligent Implant Systems Receives 510(k) Clearance for 2-Level Revolution System
Intelligent Implant Systems received FDA 510(k) clearance to market 2-level components for the Revolution™ Spinal System, allowing for use in 2-level posterior thoracolumbar fusion.
New Product Launches from NuVasive
NuVasive announced launch of new products such as AttraX® Putty Biotextured™ bone graft, the Reline® Modular system, next-gen MAS® TLIF 2 technology, etc.
Pinnacle Spine Granted Chinese Patent for InFill Spinal Fusion Technology
The Chinese Patent Office is issuing Patent Application No. 201180020517.1, "Intervertebral Implants and Graft Delivery Systems and Methods," as an enforceable patent for Pinnacle Spine, covering InFill® fusion technology.
Study Results Show Benefits of SI Joint Fusion after Two Years
Results from a 2-year study of SI-BONE's iFuse implant for sacroiliac (SI) joint fusion show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years.
First Clinical Cases with Life Spine’s GRUVE Anterior Cervical Plate
Life Spine announced initial clinical cases with the GRUVE™ Anterior Cervical Plate. Full launch is slated for 2Q16.
RTI Surgical Launches Deformity Instrumentation for Streamline TL Spinal Fixation System
RTI Surgical launched deformity instrumentation for the Streamline® TL Spinal Fixation system for treatment of complex adult deformities or curvatures in the thoracolumbar spine.
K2M MESA Mini and DENALI Mini Spinal Systems Receive Additional FDA Clearance in Posterior Cervical Spine
K2M received FDA 510(k) clearance for expanded indications of its MESA® Mini and DENALI® Mini spinal systems for stabilization of the posterior cervical and thoracic spine as an adjunct to fusion.
Interventional Spine Launches Next-Gen Opticage Lumbar Interbody Fusion Implants
Interventional Spine launched its next-generation Opticage® Lumbar Fusion line, including recent size additions and lordotic versions.
SpineSource Launches Expandable Lumbar Interbody Cage in U.S.
SpineSource commenced U.S. launch of the titanium alloy L-Varlock Lumbar Cage, reportedly the only expandable interbody that can adjust in situ from 0° to 24° of lordotic angle and up to 7mm of expansion.
Zyga Enrolls First Patients in Expanded Clinical Study on Sacroiliac Joint Fusion
Zyga Technology enrolled the 1st 4 patients in an expanded EVoluSIon Clinical Study evaluating long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.
Renovis Surgical Receives FDA Clearance of Tesera SC Cervical Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera™ SC porous titanium cervical interbody fusion system.
Wenzel Spine Announces Limited Release of the Next-Gen VariLift-LX
Wenzel Spine commenced limited launch of the VariLift®-LX system for minimally invasive lumbar fusion. Full launch is planned for spring 2016.
NuVasive Receives Regulatory Approval of ReLine™ Posterior Fixation in Japan
NuVasive received regulatory approval for ReLine™ posterior fixation technology in Japan. Launch will commence later in 2016 and continue into 2017.
Nanovis Receives NIH Research Grant
Nanovis received an NIH grant supporting pre-clinical studies of FortiCore® deeply-porous interbody fusion devices, enhanced with nanotube technology.
Medtronic Launches AVILA Interbody Fusion Devices in the EU
Medtronic commenced EU launch of AVILA™ devices, intended for use in open and minimally invasive anterior and oblique lumbar interbody fusion from L2-S1 levels.
Life Spine Receives FDA Clearance for PROLIFT Expandable Interbody System
Life Spine received FDA 510(k) clearance to market the PROLIFT® Expandable Interbody System for use in minimally invasive PLIF, TLIF and oblique approaches.
ulrich medical USA Launches uNion Cervical Plate
ulrich medical USA launched uNion®, a titanium alloy cervical plate for stabilization and anterior fixation as an adjunct to fusion.
Xtant Medical Receives CE Mark for Aranax and Irix-A
Xtant Medical received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.
Stryker Launching Xia 4.5 Cortical Trajectory Line for LITe LIF Procedures
Stryker Spine is launching Xia 4.5 Cortical Trajectory implants and instruments for LITe® Lumbar Interbody Fusion.
Amedica and Celling Biosciences to Collaborate on Spinal Fusion Devices
Amedica and Celling Biosciences will co-develop spinal fusion devices based on silicon nitride technology plus stem cell-based therapies.
Stryker Spine Launching Aero-C Cervical Stability System
Stryker Spine is launching the Aero®-C Cervical Stability System, reportedly the only ACDF device to offer uniform compression across the interbody space.
Bone Biologics Completes $5.75 Million Funding Round
Bone Biologics completed a US $5.75MM funding round to support development of a bone graft substitute for initial focus on spinal fusion.
Spine Wave Licenses Patents from Atlas Spine
Spine Wave licensed True Position® Pivoting Interbody Spacer IP from Atlas Spine.
RTI Surgical Announces Limited Launch of Unison-C Anterior Cervical Fixation System
RTI Surgical commenced limited launch of the Unison™-C anterior cervical fixation system.
ALLOB Phase IIA Spinal Fusion Trial Update
Bone Therapeutics has treated 12 patients in the ALLOB® Phase IIA spinal fusion trial, and reports no safety concerns.
National Government Services Issues Coverage for MIS SI Joint Fusion
National Government Services issued a positive local coverage determination for MIS SI joint fusion, including SI-BONE's iFuse procedure, effective 4/1/16.
Strategic Orthopaedic-related 510(k)s issued in January 2016
Strategic orthopaedic-related 510(k)s issued in January 2016 include: Half Dome PLIF System (Astura Medical*), Cannulated Screw System (Epic Extremity*), Rosa Spine (Medtech*), IFS Fixation Scaffold (Metric Medical), dynaMX MX Tabbed Staple (MX Orthopedics), Hard Carbon Coated Drill Bit (Renovo Life*), Polyscrew Pedicle Fixation System (Senecka Spine*), Interbody System (Spine Innovation*), VerteLP IBF Device (VGI Medical*)
Wenzel Spine Receives FDA 510(k) Clearance for VariLift-LX
Wenzel Spine received FDA 510(k) clearance to market VariLift®-LX as a lumbar interbody fusion device for standalone use.
Amendia Launches OmegaLIF™ Expandable Interbody Cage
Amendia launched OmegaLI