Spinal 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.

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.

Globus Medical announced the first implantation of HEDRON IA, a 3D-printed integrated anterior lumbar interbody fusion spacer.

Medicrea achieved the milestone of more than 5,000 procedures using the UNiD® ASI platform and patient-specific spinal implants.

Osseus Fusion Systems commenced alpha launch of the Aries™-TS 3D-printed transforaminal lumbar interbody fusion device.  

SpineCraft completed the ASTRA product platform with launch of its Occipito-Cervico-Thoracic system for use in posterior cervical fusion.

Inspired Spine achieved the milestone of completion of 1,000 Oblique Lateral Lumbar Interbody Fusion procedures.

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 announced the implantation of the 25,000th NanoMetalene® interbody device.

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.

ulrich medical USA launched the Momentum™ Posterior Spinal Fixation System.

Medtronic launched the Mazor X Stealth Edition™ Robotic-Assisted Spine Surgery System in India.

ATEC Spine commenced full commercial launch of the SafeOp Neural InformatiX System™.

Life Spine was granted FDA 510(k) clearance to market the LONGBOW® Titanium Lateral Expandable Spacer.

NuVasive received FDA 510(k) clearance for expanded indications for the CoRoent Small Interlock™ 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 commenced limited launch of the Cervical Spine Truss System-Stand Alone™ (CSTS-SA) implant.

Life Spine commenced limited launch of the CENTERLINE® Modular Thoracolumbar Spinal System, and announced initial surgeries. Full launch is slated for early 2020.

CMS increased the Medicare Physician Fee Schedule for CPT® Code 27279, Arthrodesis Sacroiliac Joint, under which minimally invasive sacroiliac joint fusion procedures are reported.

DiFusion received FDA 510(k) clearance for the Xiphos-ZF spinal interbody device made from ZFUZE biomaterial. Product launch will occur within 4Q19.

Safe Orthopaedics received regulatory approval for SteriSpine™ LC lumbar and CC cervical cages in Japan.

Nanovis received the first FDA 510(k) clearance for a bioceramic nanotube surface that demonstrates FDA's requirements for nanotechnology.

Implanet was granted a patent in Japan for JAZZ Lock® technology, part of its JAZZ™ solutions platform to treat degenerative spine disorders.

CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber Vertebral Body Replacements.

Spineway obtained regulatory approval in Japan for its Mont Blanc minimally invasive surgical devices.

HD LifeSciences received a patent allowance notice addressing fluid channel technology employed in its interbody fusion devices. 

Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage 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 marked the milestone of 100 surgical levels implanted with the dualX™ Expanding Interbody Fusion System.

Back 2 Basics received FDA 510(k) clearance to market eCarbon anterior cervical and posterior lumbar Interbody devices.

SeaSpine marked the implantation of the 20,000th NanoMetalene® interbody device. 

MiRus received FDA 510(k) clearance to market the molybdenum alloy-based CYGNUS Anterior Cervical Plate.

Life Spine received an additional 510(k) market clearance from FDA for the PROLIFT® Expandable Spacer System, addressing new sizes.

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.

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 commenced market release of NanoSTRIP, a 100% bioactive glass synthetic biologic strip indicated for spine and orthopedic use.

Centinel Spine announced 1,000 implantations of FLX 3D-printed porous titanium interbody devices since initial launch in 3Q18.

Alphatec commenced commercial release of InVictus, a spinal fixation platform to treat a range of pathologies via MIS, open or hybrid surgical approaches.

Alphatec commenced commercial release of the IdentiTi Large Window Porous Titanium Interbody Implant for anterior lumbar interbody fusion.

joimax commenced launch of the complete line of EndoLIF® devices for lumbar interbody fusion.

Safe Orthopaedics' SteriSpine pedicle screw kits have been utilized in 23 procedures in Japan since launch in May 2019.

SeaSpine commenced full launch of the Regatta® minimally invasive lateral interbody fusion system.

icotec was granted FDA 510(k) clearance for VADER®one pedicle screws for minimally invasive and open spine procedures.

Celling Spine acquired all assets of Link Spine, and will develop spinal fusion hardware to complement its own orthobiologic product portfolio.

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 received FDA 510(k) clearance for the Luna® XD MIS expandable interbody device. Controlled launch will proceed at select centers.

Innovasis was granted FDA 510(k) clearance to market the LxHA Lateral Interbody Fusion Device.

Implanet received its first orders related to its distribution agreements with Kico Knee Innovation and SeaSpine.

Life Spine received FDA 510(k) clearance to market the PROLIFT® Lateral Expandable Spacer system.

NuVasive commenced launch of Modulus® TLIF-O, a porous titanium implant for transforaminal lumbar interbody fusion.

Medicrea was allowed three new U.S. patents relating to the company's proprietary UNiD® Adaptive Spine Intelligence software platform.

ulrich medical USA is slated to achieve the milestone of 100,000 total vertebral body replacement device implantations within the year.

RTI Surgical achieved the milestone of 5,000 implants of Fortilink®-C, -TS and -L interbody fusion systems in the U.S.

Implanet's JAZZ® Cap device has been successfully used in first U.S. spinal fusion procedures.

Zavation received FDA 510(k) clearance to market the Ti3Z lumbar interbody system.

Ozop Surgical has completed initial testing of a novel adjustable ALIF interbody spinal implant.

Globus Medical introduced AERIAL, a minimally invasive expandable interspinous fixation system.

Alphatec launched the IdentiTi-PC Porous Titanium Interbody Implant for TLIF.

CoreLink introduced a lateral access and interbody fusion platform comprising tissue retractor options and F3D titanium alloy and CL5 PEEK lateral interbody implants.

Innovasis' HA PEEK Data Registry achieved significant enrollment of 150 patients since its 2018 launch.

ChoiceSpine received FDA 510(k) clearance to market the TIGER SHARK C interbody device and the BOOMERANG Anterior Cervical Plate.

Medtronic entered into a definitive agreement to acquire Titan Spine, a titanium spine interbody implant and surface technology company.

WishBone Medical purchased CSpine, manufacturer of spine and orthopedic implants and instruments. 

Alphatec launched the PLIF IdentiTi-PS Porous Titanium Interbody for PLIF, and AlphaGRAFT® DBM Fiber. 

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 received regulatory registration in Japan for the SteriSpine PS system to treat spinal fractures.

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 received an additional FDA 510(k) clearance for use of iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.

NuVasive is introducing the X360 system integrated with Pulse automation for lateral single-position surgery. 

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 received expanded FDA 510(k) clearance for the HAWKEYE Ti vertebral body replacement for use in the cervical spine.

NuVasive announced initial XLIF® spinal procedures using the Cohere® XLIF lateral Porous PEEK device.

Alphatec announced commercial release of the IdentiTi-C Porous Titanium Interbody for ACDF.

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 received FDA 510(k) clearance for the Europa pedicle screw made of MoRe® molybdenum rhenium superalloy material.

SpineEX gained additional FDA clearance for the Sagittae Lateral Lumbar Interbody Fusion system, covering new instrumentation and an updated surgical technique.

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 received FDA 510(k) clearance to market JAZZ Cap® to secure screws in poor quality bone in vertebral fusion procedures.

iOrthopedics introduced the Gobi Spine Cage, evolving from its Uniformly Expanding Cage patents toward 50% expansion uniformly, proximally or distally.

Kuros Biosciences received FDA clearance to market the Kuros TLIF cage.