Regulatory

OrthoGrid Systems received FDA 510(k) clearance to market a PhantomMSK Trauma application for intraoperative surgical imaging.

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.

Conformis received FDA 510(k) clearance for a next-generation Conformis Hip System.

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.

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.

Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage System.

Turner Imaging Systems received FDA 510(k) clearance to market the Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.

curasan is launching Spinevisc® hyaluronic acid for the treatment of facet syndrome.

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

DeGen Medical received FDA clearance to market the F1 MPS Modular Pedicle Screw System for JOUST Minimally Invasive Surgery and the Cyclops Anterior Cervical Plate.

SpineWelding received its first FDA 510(k) clearance, addressing the Elaris Pedicle Screw.

Life Spine was granted FDA 510(k) clearance to market a Hinged Laminoplasty System.

CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber fenestrated pedicle screws to treat spinal tumors. 

Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement.

Viseon announced FDA 510(k) clearance and initial clinical use of Voyant high-definition real-time imaging technology for minimally invasive spine surgery.

Zimmer Biomet was granted FDA 510(k) clearance for the JuggerStitch device for meniscal repair.

Arthrosurface received FDA 510(k) clearance to market the BOSS Toe Fixation system, a motion-preserving alternative to toe fusion.

4WEB received FDA 510(k) clearance for its Cervical Spine Truss System-Stand Alone interbody.

ApiFix received Humanitarian Device Exemption approval to market the MID-C Minimally Invasive Deformity Correction system to treat adolescent idiopathic scoliosis.

DiscGenics was granted Fast Track designation from FDA for its investigational cell therapy, IDCT, under evaluation in clinical trials in the U.S. and Japan to treat pain and disability from degenerative disc disease.

aap Implantate received FDA 510(k) clearance to market LOQTEQ® variable angle calcaneus plates 3.5 to treat heel fractures. 

OrthoPediatrics received FDA 510(k) clearance to market the PediFoot Deformity Correction system. Product launch is slated for 3Q19.

Cutting Edge Spine received FDA 510(k) clearance to market EVOL-SI, a sacroiliac joint fusion system.

Zimmer Biomet received FDA approval for The Tether, a vertebral body tethering system that offers an alternative to fusion in the treatment of pediatric scoliosis.

Medicrea received FDA clearance to market the TULIP GENESIS top loading screw, the final element in its UNiD ASI spine surgical planning platform.

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.

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.

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.

OrthoPediatrics received FDA 510(k) clearance to market its next-generation Cannulated Screw to treat smaller stature patients.

aap Implantate received FDA 510(k) clearance to market LOQTEQ® VA foot plates 2.5. Launch will commence in 2020.

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.

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

Aidoc was granted FDA 510(k) clearance to market an artificial intelligence solution to triage cervical spine fractures.

DT MedTech was granted FDA premarket approval for the Hintermann Series H3 three-piece total ankle.

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

Ignite Orthopedics received FDA 510(k) clearance to market a Radial Head Arthroplasty System, its first product to be cleared.

Metalogix received FDA 510(k) clearance for the Revolution External Plating open ring fixation system.

AMDT Holdings received FDA 510(k) clearance to market SixFix, a hexapod external fixation device.

ControlRad launched ControlRad Trace for mobile C-arms, technology that can reduce unnecessary radiation up to 89% during fluoroscopic imaging.

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

Treace Medical Concepts received FDA clearance to expand indications of the Lapiplasty® 3D Bunion Correction system to treat pediatric patients.

Konica Minolta Healthcare Americas received FDA 510(k) clearance to market Dynamic Digital Radiography enhanced x-ray imaging that can capture movement in a single exam.

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

Orthofix Medical announced first commercial U.S. implants of the M6-C cervical disc following FDA Premarket Approval of the device.

Small companies around the world continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or first FDA 510(k) in a new market segment. The companies and products we mention here are excerpted from chapters of the upcoming 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.

Medicrea enhanced the UNiD ASI (Adaptive Spine Intelligence) platform with addition of a device selection and surgical planning service, integrating a complete database of all Medicrea spine implants.

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.

Collagen Matrix received FDA 510(k) clearance to market OssiMend® Bioactive Moldable Bone Graft Matrix.

Nextremity Solutions received FDA 510(k) clearance to market Stratum, a comprehensive system of plates indicated for fixation of small bones and bone segments in the foot.

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

Intellirod Spine gained FDA de novo clearance for the LOADPRO® disposable spinal rod strain sensor, initially for use with Xtant Medical's FORTEX pedicle screw.

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.

Zimmer Biomet received FDA 510(k) clearance to market the ROSA® ONE Spine System for robotically-assisted spine procedures.

Atreon Orthopedics received FDA 510(k) clearance to market the Rotium Bioresorbable Wick for the treatment of rotator cuff injuries.

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

Exactech received FDA 510(k) clearance to market the Alteon® Acetabular Cup and XLE® Liner for hip reconstruction.

AxioMed was issued approval under the CE Mark for their viscoelastic cervical disc replacement.

Nvision Biomedical Technologies received FDA 510(k) clearance to market the Vector Hammertoe Correction System, the first foot/ankle implant made from PEEK.

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

Maxx Orthopedics received FDA 510(k) clearance to market the Freedom® Ultra-Congruent liner for the Freedom Knee® system.

CurvaFix was granted FDA 510(k) clearance to market the CurvaFix® Intramedullary Rodscrew for less-invasive pelvic trauma surgery.

Vertos Medical received CE Mark approval for the mild® device kit for the treatment of lumbar spinal stenosis.

OrthoGrid Systems received FDA 510(k) clearance to market PhantomMSK distortion adaptation technology for use in orthopedic surgery.

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.

NuVasive received FDA 510(k) clearance and CE Mark approval to market Precice® Bone Transport, an all-internal treatment for segmental bone loss in the tibia and femur.

SIG Medical received FDA 510(k) clearance for its enhanced AdvantageRib system for rib fracture repair. Full U.S. launch will occur within 1Q19.

Intrinsic Therapeutics gained FDA Premarket Approval for the Barricaid annular closure device.

Orthofix Medical received FDA Premarket Approval for the M6-C artificial cervical disc. 

SIRAKOSS received approval under the CE Mark for Osteo3 nanosynthetic bone graft substitute.

Gramercy Extremity Orthopedics received FDA 510(k) clearance for its GEO® Nitinol Staple for fixation of small bone fragments, osteotomies and joint arthrodesis.

Additive Orthopaedics received FDA 510(k) clearance to market Patient Specific 3D Printed Locking Lattice Plates for use in small bones.    

OSSIO received FDA 510(k) clearance to market OSSIOfiber bone pins, made of a bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind. 

JointPoint obtained Health Canada licenses for ELITE and PRO surgical navigation systems, allowing for immediate deployment of these products in the region.

Zimmer Biomet received FDA 510(k) clearance to market the ROSA® Knee System for robotically-assisted total knee replacement.

Episurf Medical received FDA approval for its IDE application to commence a clinical study of the Episealer® knee device.

PeekMed® received FDA 510(k) clearance to market its 3D pre-operative planning software.

DiscGenics received approval in Japan to advance into clinical studies of IDCT allogeneic injectible disc cell therapy for the treatment of lumbar degenerative disc disease.

Kuros Biosciences was granted FDA 510(k) clearance to market MagnetOs Putty as a standalone bone graft in the extremities and pelvis. 

NuVasive received FDA 510(k) clearance to market an expanded indication for the Monolith® corpectomy system in the cervical spine.

United Orthopedic received FDA 510(k) clearance to market the E-XPE vitamin E highly cross-linked polyethylene-based hip liner.

OrthoXel was granted approval under the CE Mark for the Apex Tibial Nailing System.

SIG Medical received FDA 510(k) clearance to market the AdvantageRib® intrathoracic and anterior rib plating system.

BioPoly received FDA approval to conduct an IDE clinical study of the BioPoly® RS Partial Resurfacing Knee.

Simplify Medical completed enrollment and treatment of all patients in its U.S. Investigational Device Exemption pivotal trial evaluating the Simplify® Disc for two-level cervical disc replacement.

CartiHeal announced successful enrollment of the first patient in the Agili-C IDE pivotal study on the East Coast.

Bio2 Technologies received FDA approval to enroll subjects in an IDE clinical study of Vitrium bioactive glass as a cervical interbody fusion device.

NuVasive received FDA 510(k) clearance for the COHERE® Porous PEEK device in eXtreme Lateral Interbody Fusion.

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.

Siemens Healthineers received FDA clearance to market Cios Spin, a mobile C-arm that provides interoperative 3D imaging for orthopaedic procedures.

Shoulder Innovations received FDA 510(k) clearance to market the InSet Humeral Short Stem.

Medacta received FDA 510(k) clearance to market the GMK® Sphere “ Kinematic Alignment surgical technique and technique-specific instruments for total knee arthroplasty.

Innovasive received FDA 510(k) clearance to market the DualX titanium dual expanding interbody device for lumbar fusion procedures.

Zimmer Biomet received FDA 510(k) clearance to market the PERSONA® revision knee, featuring patient-specific components.

CartiHeal has successfully enrolled and treated the 100th patient in the pivotal IDE study of the Agili-C implant. 

Regentis Biomaterials expanded the SAGE clinical trial of GelrinC to 11 U.S. sites. The investigational device is in evaluation to regrow knee cartilage.

Centric Medical received FDA 510(k) clearance to market its SATURN external fixation system.

Viseon received FDA 510(k) clearance to market the Voyant System for Minimally Invasive Spine Surgery access, visualization and illumination. 

X-Bolt Orthopaedics achieved FDA 510(k) clearance for X-Bolt Hip Nailing and Hip Plating fixation. 

Medacta received FDA 510(k) clearance to market its Mpact 3D Metal and Augments 3D Metal implants for use in total and revision hip arthroplasty.

K2M received additional FDA 510(k) clearance for the MESA® Spinal System, supporting use of sagittal plane correction in idiopathic scoliosis.

SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar interbody fusion. 

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.

FDA approved an update to the labeling for Zimmer Biomet's Mobi-C® Cervical Disc to include 7-year clinical results, showing the device to be statistically non-inferior in overall study success for 1-level use and statistically superior in overall study success for 2-level use.

Baxter was granted FDA 510(k) clearance to market ALTAPORE Bioactive Bone Graft as an autograft extender in posterolateral spinal fusion.

Renovis Surgical received FDA 510(k) clearance to market the Tesera® X Lateral Interbody Fusion system.

Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw. 

OrthoXel received FDA 510(k) clearance to market the Apex Femoral Nailing System. 

Stryker received FDA 510(k) clearance for the SpineJack® implantable reduction system to treat osteoporotic vertebral compression fractures.

Synergy Biomedical received FDA 510(k) clearance to market BIOSPHERE® FLEX bone graft. 

Synergy Biomedical received FDA 510(k) clearance and commenced full launch of BIOSPHERE® MIS PUTTY for open, mini-open and percutaneous minimally invasive procedures.

b-ONE Ortho received FDA 510(k) clearance to market the b-ONE cementless total hip system.

TranS1 announced NICE recommendation for approval of the AxiaLIF® system and presacral approach among standard arrangments to treat severe chronic low back pain. 

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.

SpineVision received FDA (510)k clearance and CE Mark approval for the 3D-printed HEXANIUM TLIF cage.

IlluminOss Medical received additional FDA clearance for the IlluminOss Bone Stabilization System to treat impending and pathological fractures.

Captiva Spine announced FDA 510(k) clearance for the TowerLOX-EXT® MIS Extended Tab pedicle screw.

Genesys Spine announced FDA 510(k) clearance and launch of the AIS-C Stand-Alone interbody system for cervical spine.

Baxter International received FDA 510(k) clearance for its Actifuse Flow bone graft substitute. 

Captiva Spine announced FDA 510(k) clearance and launch of the TirboLOX-L 3D-printed titanium lumbar cage.

Eden Spine received FDA 510(k) clearance to market the SPHYNX thoracolumbar locking plate.

Ceterix Orthopaedics received FDA 510(k) clearance of a size 0 suture cartridge for use with the NovoStitch® Pro Meniscal Repair System. 

Zimmer Biomet received an FDA Warning Letter related to observed non-conformities with current good manufacturing practice requirements at the company's North Campus facility in Warsaw, Indiana.

Osseus Fusion Systems received FDA 510(k) clearance to market Aries 3D-printed lumbar interbody fusion devices.

CartiHeal announced successful enrollment of the first two U.S. patients in the Agili-C IDE pivotal study.

CoreLink received FDA 510(k) clearance to market the Foundation 3D Anterior Lumbar Interbody Fusion device.

Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm. 

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.

Episurf Medical is entering its next phase on its IDE application to initiate a U.S. clinical study of the Episealer® knee implant. 

Cerapedics enrolled the first patients in an IDE clinical trial evaluating P-15L Bone Graft vs. autograft in TLIF.

NuVasive received FDA 510(k) clearance to market Pulse surgical automation, the foundation for the company's Surgical Intelligence system.

CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological patients.

FBC Device received its first FDA 510(k) clearance, granted for the FBC 921 ALIF interbody implant.

K2M received FDA 510(k) clearance and CE Mark approval for the CAYMAN® United Plate.

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.

Cutting Edge Spine received FDA 510(k) clearance to market the EVOL ha-C cervical interbody system. 

Arthrosurface gained FDA 510(k) clearance to market the Patellofemoral WaveKahuna Arthroplasty System.

Corin received FDA 510(k) clearance to market the Trinity PLUS acetabular cup. 

Lipogems received FDA 510(k) clearance to market a Microfragmented Adipose Tissue Transplant system for use in orthopaedic and arthroscopic procedures. 

By the end of 2Q18, Episurf Medical will file for its Investigational Device Exemption with FDA to initiate a U.S. study of the Episealer® knee implant.

Renovis Surgical Technologies received FDA 510(k) clearance to market Tesera® SA Hyperlordotic ALIF, a standalone interbody fusion system.

Zimmer Biomet published a response to the Form 483 issued by FDA in April 2018, related to inspectional observations at the Warsaw North Campus manufacturing facility.

To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here's what I found.

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.

Medtronic gained FDA 510(k) clearance for Kyphon HV-R Bone Cement for use in sacroplasty.

Arcuro Medical received FDA 510(k) clearance to market its SuperBall all-suture meniscus repair system for the knee.

Medacta received FDA 510(k) clearance for a Short Humeral Diaphysis used with the Medacta Shoulder System. 

Wright Medical received FDA premarket approval for AUGMENT® Injectable Bone Graft, serving as an alternative to autograft in hindfoot and ankle fusion.

Centinel Spine received FDA 510(k) clearance to market the FLX platform of Integrated Interbody and non-integrated interbody fusion devices.

EOS imaging received FDA 510(k) clearance to market hipEOS 3.0 surgical planning software for THA.

Diamond Orthopedic received FDA 510(k) clearance for sterile packaged faceted bone screws.

Spineology received FDA 510(k) clearance to market the Rampart One Standard ALIF device without supplemental fixation.

Camber Spine received FDA 510(k) clearance to market the ENZA-A Titanium Anterior Lumbar Interbody Fusion system.

Medicrea obtained what is reported to be the first FDA 510(k) clearance to market patient-specific spinal cages.

Imagen received FDA de novo clearance to market OsteoDetect software designed to detect adult wrist fractures.

K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices. 

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.

Life Spine received FDA 510(k) clearance to market additional indications for the PRO-LINK® Ti Stand-Alone Cervical Spacer.

Providence Medical Technology announced FDA 510(k) clearance to market its DTRAX® system for use in posterior cervical fusion.

Xtant Medical received FDA 510(k) clearance for its InTice-C Porous Titanium Cervical Interbody System.

Additive Orthopaedics received FDA 510(k) clearance to market Patient Specific 3D-Printed Bone Segments for ankle and foot fixation.

FDA performed an inspection of Zimmer Biomet's Warsaw North Campus manufacturing facility in April 2018, and issued a Form 483 with 11 inspectional observations. 

OrthoPediatrics received FDA 510(k) clearance to market its Pediatric Nailing Platform | FEMUR.

CurveBeam received FDA 510(k) clearance to market its LineUP multi-extremity CT System.

Nextremity Solutions received FDA 510(k) clearance to market the InCore Lapidus system for forefoot fusion.

Kuros Biosciences received CE Mark approval for MagnetOs Putty bone void filler.

Paradigm Spine was granted a supplemental FDA PMA for the coflex® Interlaminar Stabilization® disposable instrument kit.

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.

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.

Carestream Health received a Health Canada Class III License for the CARESTREAM OnSight 3D Extremity imaging system. 

Advanced Biomedical Technologies received approval from China's FDA for polymer orthopaedic internal fixation screws.

Arthrosurface received FDA 510(k) clearance to market OVOMotion, a stemless total shoulder arthroplasty system to treat damage from arthritis, trauma or Avascular Necrosis.

Ceterix Orthopaedics received FDA 510(k) clearance to market its next-generation NovoStitch® Pro Meniscal Repair system. 

CurveBeam received CE Mark approval for LineUP and InReach, compact orthopaedic extremity CT systems.

CTL Medical gained FDA 510(k) clearance to market the SEURAT Universal Pedicle Screw. The product is slated for 2H18 launch.

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.

Orthofix received FDA 510(k) clearance to market the G-Beam Fusion Beaming system to treat neuropathic deformities such as Charcot foot.

Exactech received FDA 510(k) clearance to market Novation XLE Vitamin E acetabular polyethylene liners for hip replacement.

Life Spine received FDA 510(k) clearance to market the PLATEAU®-LO Insert and Rotate Spacer system for lumbar interbody fusion. 

Trice Medical received regulatory approval in Canada and the EU for the mi-eye 2 direct visualization tool.

Orthopedic Designs North America received FDA 510(k) clearance for the Talon® DistalFix® Humeral Nail.

CTL Medical received FDA 510(k) clearance for the MATISSE Ti-PEEK ACIF cage, featuring TiCro surface technology.

Exactech received FDA 510(k) clearance to market the Equinoxe® Stemless Shoulder for total shoulder arthroplasty. 

Panther Orthopedics received FDA 510(k) clearance to market PUMA, a flexible system indicated for various foot/ankle repair applications.

Orthofix gained FDA premarket and CE Mark approval for next-gen PhysioStim bone growth stimulators, used as a nonsurgical treatment for nonunion fracture in the extremities.

Globus Medical debuted its FDA-510(k)-cleared trauma products, comprising fracture plates, compression and cannulated screws, intramedullary nails and external fixation. 

Amedica announced FDA 510(k) clearance of the Valeo C+CsC with Lumen interbody fusion device.

Synergy Biomedical received Therapeutic Goods Administration clearance and commenced launch of BIOSPHERE PUTTY bioactive bone graft in Australia.

Emerging Implant Technologies gained expanded FDA clearance to market EIT Cellular Titanium® Cervical Cages for multiple contiguous levels.

Orthofix received FDA 510(k) clearance to market the FORZA® XP Expandable Spacer for posterior and transforaminal lumbar interbody fusion.

Centric Medical received FDA 510(k) clearance for a new foot and ankle plating system for calcaneal slide osteotomy and metatarsal phalangeal, lapidus and midfoot fusion.

Episurf Medical received approval to market Episealer® knee products in Israel, to be distributed by AMI Technologies.

Centric Medical received expanded FDA 510(k) clearance to market its Cannulated Screw Internal Fixation System in foot/ankle reconstruction. 

BioPoly received CE Mark approval for the RS Partial Resurfacing Trochlea system, and will launch product within coming months.

OrthoXel gained both FDA 510(k) clearance and CE Mark approval for the Apex Tibial Nailing system.

ORTHOReBIRTH USA received FDA 510(k) clearance to market ReBOSSIS® biosynthetic bone scaffold for use in posterolateral spine procedures.

Bodycad received a Health Canada license and clearance to market Bodycad OnCall personalized cutting guides.

IlluminOss Medical received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures. U.S. launch is slated for 2Q18.

Zimmer Biomet received FDA 510(k) clearance for the Sidus® Stem-Free total shoulder. The device will launch within 1Q18.

NuVasive launched COALESCE for Thoracolumbar Interbody Fusion, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion device with expanded indications.

Anika Therapeutics received FDA 510(k) clearance to market a resorbable, injectable hyaluronic acid-based bone void filler.

K2M received approval under the CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage, and announced completion of its first surgical case.

FDA's Orthopaedic and Rehabilitation Devices Panel recommended against Premarket Approval of Intrinsic Therapeutics' Barricaid Anular Closure for partial anulus replacement to treat herniated discs.

Omnia Medical received FDA 510(k) clearance to market its PEEK-OPTIMA HA-based vertebral body replacement device.

Camber Spine received FDA 510(k) clearance to market the SPIRA™-C Open Matrix cervical interbody fusion device.

In2Bones USA received FDA 510(k) clearance to market CoLink® View see-through plates for the CoLink forefoot bone plating system.

SeaSpine received FDA 510(k) clearance to market OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh.

Medicrea received FDA 510(k) clearance to market IB3D™ 3D-printed interbody devices, and introduced its AdapTEK™ in-house additive manufacturing technology.

Mortise Medical received FDA 510(k) clearance to market the SyndesMetrics' Syndesmosis Repair system.  

MedShape received FDA 510(k) clearance to market the DynaNail® XL tibiotalocalcaneal fusion system.

Extremity Medical received FDA 510(k) clearance for the Omni MTP fusion system.

DT MedTech received FDA 510(k) clearance to market the Hintermann Series H2™ Total Ankle, a semi-constrained, cemented prosthesis for primary or revision surgery.

Amedica made a (510)k submission to FDA for its Valeo C+CSC with Lumen cervical spinal implant.

IntraFuse received FDA 510(k) clearance to market the FlexThread™ Fibula Pin system. 

Intellijoint Surgical received FDA 510(k) clearance to market intellijoint HIP® navigation for revision procedures.

Pinnacle Spine expects 4Q17 FDA 510(k) clearance to market InFill® Lateral Lumbar Fusion systems with Invibio's HA Enhanced PEEK-OPTIMA material. 

Prosidyan announced FDA 510(k) clearance and commercial launch of FIBERGRAFT BG Matrix, a bone graft substitute for posterolateral spinal fusion.

Medacta received FDA 510(k) clearance to market Anatomic and Reverse Shoulder components for its modular Medacta Shoulder system. U.S. launch will occur in 1Q18.

ChoiceSpine received FDA 510(k) clearance to market Blackhawk™, an integrated, self-locking anterior cervical fusion device.

FzioMed received FDA approval to conduct a small confirmatory study of Oxiplex® synthetic viscoelastic gel, examining its use following lumbar surgery.

Implanet received approval under the CE Mark to market the JAZZ® Passer, used in posterior fixation procedures.

Anika Therapeutics received Australia regulatory approval to market MONOVISC® single-injection viscosupplement for the treatment of osteoarthritis pain in all synovial joints. 

Stryker received FDA 510(k) clearance to market the Mako total knee application with Triathlon cementless components.

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.

NuVasive received expanded FDA 510(k) clearance for the PRECICE® limb lengthening system.

OrthAlign received Australian Therapeutic Goods Administration approval of DAA HipAlign® for Direct Anterior Approach Total Hip procedures and UniAlign® for Partial Knee Arthroplasty.

Intellijoint Surgical received CE Mark approval for intellijoint HIP®, a 3D mini-optical navigation system. EU market launch is slated for 2018.

Nexxt Spine received FDA 510(k) clearance to market 3D-printed NEXXT MATRIXX™ interbody and vertebral body replacement devices. 

ChoiceSpine received FDA 510(k) clearance to market the HAWKEYE Ti vertebral body replacement, its first 3D-printed device.

OrthAlign received CE Mark Approval to market the DAA HipAlign® Direct Anterior Approach Total Hip system and UniAlign® Unicompartmental Knee Arthroplasty.

FDA accepted DiscGenics' Investigational New Drug Application for a clinical study of its cell therapy product candidate to treat degenerative disc disease.

K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine. 

Subchondral Solutions received FDA 510(k) clearance to market the fenestrated, cannulated S4 Screw System™ to treat osteochondral fractures.

Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 expandable interbody cage.

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 received FDA 510(k) clearance and commenced U.S. launch of NanoHive™, a system of interbody devices for ALIF, PLIF and TLIF procedures.

Mortise Medical received FDA 510(k) clearance to market the LigaMetrics™ Suture Anchor for ankle injury repair.  

Mazor Robotics received CE Mark approval for the Mazor X Surgical Assurance Platform. 

Stryker Spine received FDA 510(k) clearance to market its 3D-printed Tritanium® C Anterior Cervical Cage. 

Xtant Medical received FDA 510(k) clearance to market line extensions for the Irix-A standalone interbody spacer.

IMPLANET received FDA 510(k) clearance to market JAZZ™ Passer, a system of spinal instruments and braided band technology.

Spinal Resources received FDA 510(k) clearance to market the Swedge™ Pedicle Screw system.

OMNIlife science received FDA 510(k) clearance to market Active Spacer, a robotic tissue balancing device for use with OMNIBotics® robotic-assisted total knee replacement technology.

NuVasive received FDA 510(k) clearance for use of redesigned MAGEC® growing rods with the RELINE® Small Stature pediatric deformity fixation system.

Bioventus received FDA premarket approval for DUROLANE single-injection hyaluronic acid to treat pain associated with knee osteoarthritis.

Regentis Biomaterials received CE Mark approval for a GelrinC biodegradable implant based on denatured human fibrinogen for the treatment of articular knee cartilage defects.

Kuros Biosciences received FDA 510(k) clearance to market MagnetOs synthetic bone graft putty as an autograft extender in the posterolateral spine.

Globus Medical received FDA 510(k) clearance to market the Excelsius GPS™ robotic guidance and navigation system.

Stryker Spine received FDA 510(k) clearance to market the Serrato™ Pedicle Screw.

Strategic orthopaedic-related 510(k)s issued in July 2017 include: EIT Cellular Titanium Cages (EIT Emerging Implant Technologies), Lumbar Interbody System (HD LifeSciences), Gemini-C Hybrid Cervical Interbody System (Osseus Fusion Systems), LumFuse-TP (Precifit Medical), Anchorman Tibial Ligament Fixation (Summit Medical)

Camber Spine Technologies received FDA 510(k) clearance and commenced U.S. launch of the SPIRA™ Open Matrix ALIF device, manufactured with additive techniques. 

Renovis Surgical received FDA 510(k) clearance to market Tesera® 3D-printed posterior lumbar interbody fusion systems.

ApiFix received regulatory approval to market the ApiFix system in Australia to treat Adolescent Idiopathic Scoliosis.

In2Bones USA received FDA 510(k) clearance for 5MS™ Fracture Repair and CoLag™ Locking Compression Screw systems for extremity repair.

CTL Medical received FDA 510(k) clearance to market the MATISSE™ titanium ACIF cage.

Providence Medical Technology was granted regulatory approval in Australia for DTRAX® cervical fusion devices.

Vertera Spine received FDA 510(k) clearance to market the COALESCE™ interbody fusion device for ALIF, TLIF, PLIF and LLIF procedures. 

Anika Therapeutics received regulatory approval in India for MONOVISC® viscosupplement to treat OA pain in all synovial joints.

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.

Emerging Implant Technologies received FDA 510(k) clearance for 3D-printed spinal interbody devices to address ALIF, PLIF, TLIF and cervical procedures.

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)

Extremity Medical announced FDA 510(k) clearance of the Axis Charcot fixation system. 

Tyber Medical received FDA 510(k) clearance for the TyFix™ all-in-one extremity fixation system.

Stryker received FDA 510(k) clearance for the MultiGen 2 RF Generator for radiofrequency ablation to treat facet joint pain. 

K2M received FDA 510(k) clearance and approval under the CE Mark for the NILE® Proximal Fixation system to treat complex spinal deformity.

Meditech Spine received FDA 510(k) clearance for its CURE Lumbar Plating System, expected to be packaged as comprehensive solution with Talos.  

Spineology enters anterior market with FDA cleared Rampart One Interbody Fusion System.

Additive Orthopaedics received FDA 510(k) clearance for its 3D-printed intramedullary Bunion Correction System. 

ConforMIS received FDA 510(k) clearance of the iTotal Hip replacement system. Limited launch is slated for 2019.

Strategic orthopaedic-related 510(k)s issued in May 2017 include: Locking Plate System (Beijing KeYi Medical Device), Collagen Meniscus Implant XL (Ivy Sports Medicine), Kirschner Wires (Precifit Medical), SICAGE System (Sicage), MALUC Total Hip Arthroplasty System (SurgTech)

Meditech Spine received FDA 510(k) clearance for Talos® Lumbar PEEK IBF devices enhanced with hydroxyapatite.

Medicrea received FDA 510(k) clearance for UNiD™ HUB, a data-driven digital portal that employs Adaptive Spine Intelligence for surgical planning.

Medicrea received FDA 510(k) clearance and performed first surgeries with PASS® TULIP top-loading fixation.

FDA notified Zimmer Biomet that a Warning Letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility has been closed out.

SI-BONE received FDA 510(k) clearance and commenced full U.S. launch of the iFuse-3D™ Implant.

CMS issued a new ICD-10 code for a radiolucent porous interbody fusion device, supporting Vertera Spine's COHERE cervical device. 

Mazor Robotics disclosed that last month, the Israeli Securities Authority performed a search and queried certain of the company's officers.

Expanding Orthopedics announced CE Mark approval and launch of the FLXfit™15 interbody cage.

Medovex received CE Mark approval for the DenerveX™ system.

Prosidyan received FDA 510(k) clearance of FIBERGRAFT BG Putty for use in posterolateral spinal fusion. 

Orthocell received confirmation that Ortho-ACI® Autologous Chondrocyte Implantation is included on the Australian Register of Therapeutic Goods.

VEXIM received regulatory approval from ANVISA to commercialize SpineJack® in Brazil.

Bodycad received product notification confirmation which enables them to commercially launch their Unicompartmental Knee System within the European Union.

Globus Medical plans to resubmit its 510(k) for the ExcelsiusGPS™ system to FDA, and noted that its clearance is now expected after 2Q17.

XpandOrtho received FDA 510(k) clearance for an electronic soft tissue balancing instrument for total knee replacement that is compatible with almost all total knee systems from major manufacturers.

Strategic orthopaedic-related 510(k)s issued in April 2017 include: ExactechGPS Total Shoulder Application (Exactech filing as Blue Ortho); Locking Bone Plates and Screws Osteosynthesis Plating System, DHS/Dynamic Condylar Plate (Greens Surgicals); AX Standalone ALIF System (Innovasis); Mazor X (Mazor Robotics); PRECICE UNYTE CoCr System (NuVasive Specialized Orthopedics); NovoGro Putty (OsteoNovus); Balanced Plating System (Pantheon Medical); Yellowstone Lumbar Interbody Fusion System (Summit Spine); XO1 Knee Balancing System (XpandOrtho)

Exactech received FDA 510(k) clearance to market the ExactechGPS® Shoulder Application. Initial U.S. launch is slated for 2Q17.

Episurf Medical commenced internal actions to select its regulatory pathway for application for U.S. market acceptance. A decision is expected by 3Q17. 

OrthAlign received Japan regulatory approval to market Direct Anterior HipAlign® for use in supine position THA and UniAlign™ for UKA, to be distributed by Zimmer Biomet Japan.

Life Spine received FDA 510(k) clearance of its CRANIAL FUSION system, expanding indications for use of SOLSTICE Polyaxial Screws into the cervical spine.

ZipLine Medical received regulatory approval of the Zip® Surgical Skin Closure device in India. 

Histogenics successfully completed consultations with Japan's PMDA regarding the regulatory path for NeoCart® autologous cell therapy for the treatment of knee cartilage defects. 

Implanet received approval under the CE Mark for the JAZZ™ Standalone implant for posterior spinal fixation.

Innovasis received FDA 510(k) clearance to market Ax™, a standalone system for anterior lumbar interbody fusion. 

Amedica has been granted marketing clearance in Australia for Valeo® interbody fusion devices.

Ziptek received FDA 510(k) clearance to market the ZipE® knotless tissue repair and attachment device.

Life Spine announced FDA 510(k) clearance and launch of the PLATEAU®-C Ti Cervical Spacer System.

Additive Orthopaedics received FDA 510(k) clearance for a 3D-printed Locking Lattice Plating System.

Mazor Robotics received FDA clearance to market Mazor X Align™ software for use in spinal deformity correction planning. Initial launch will occur in mid-2Q17.

United Orthopedic received FDA 510(k) clearance to market the E-XPE™ polyethylene knee insert.

Strategic orthopaedic-related 510(k)s issued in March 2017 include: Joinix Cannular System (Aju Pharm), Unicompartmental Knee (Bodycad), Microfet 2 Dynamometer (Hoggan Scientific), Flex-Thread Clavicle Pin (Intrafuse), Evolution Revision Tibial System (MicroPort Orthopedics)

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.

Bodycad received FDA 510(k) clearance to market the Bodycad Unicompartmental Knee joint reconstruction system.

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 Technology received FDA 510(k) clearance for ALLY™ Facet Screws and for standalone use of the CAVUX™ Cervical Cage-L system.

Did you miss a product clearance or launch announced at AAOS? Here we've compiled a list of highlights by market segments.

NuVasive announced updated guidance from the National Industry for Clinical Excellence in the U.K. for lateral lumbar interbody fusion. 

Materialise received FDA 510(k) clearance to market its Surgicase Orthopaedics system for pre-op planning in pediatric patients undergoing radius and ulna osteotomies.

First Ray received FDA 510(k) clearance for additional sizes and materials in the Stealth Staple™ line.

DJO Global announced FDA 510(k) clearance to market the Exprt® Revision Hip.

Medtronic received FDA 510(k) clearance of Kyphon™ Xpede Bone Cement for fixation of pathological fractures of the sacral ala using sacroplasty.

Strategic orthopaedic-related 510(k)s issued in February 2017 include: NanoFuse (Amend Surgical*), Arrowhead Mini-Rail Fixator (Arrowhead), Expandable Interbody System (Atlas Spine), DCM Kyphoplasty System (Dragon Crown Medical*), Kepler I Cervical Plate (Orbbo Surgical), RASL Repair Kit/Bone Screw (Radicle Orthopaedics*), Trauma System/Plates and Screws (Surgtech), BluePrint Patient Specific Instrumentation (Tornier/Wright Medical), Intra Medullary Endo-Transilluminating Device/Arthroscope (Wemed Bio-Tech*), Prophecy INVISION Pre-operative Navigation Alignment System (Wright Medical), Magnetos Bone Void Filler (Xpand Biotechnology*)

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.

Intellijoint Surgical received FDA 510(k) clearance to market the intellijoint HIP® Anterior application for surgical navigation.

Amend Surgical received FDA 510(k) clearance to market NanoFUSE® BA as a bone graft extender for spine and orthopaedic applications.

Synergy Biomedical received approval under the CE Mark for BIOSPHERE synthetic bone graft putty.

joimax obtained full product registration from the Thai Food & Drug Administration. Certification in Japan, Malaysia and Taiwan is expected during 2017.

Centric Medical received FDA 510(k) clearance to market its Metatarsal Hemi Implant system.

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)

Spinal Simplicity received its third FDA 510(k) clearance for the Minuteman G3-R spinal implant. 

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.

Gramercy Extremity Orthopedics received FDA 510(k) clearance to market the GEO™ Bone Screw, indicated for fractures, osteotomies, arthrodesis, osteochondritis and tendon reattachment.

OrthAlign received FDA 510(k) clearance to market the Direct Anterior Approach HipAlign® system, a handheld computer that provides cup placement accuracy data and measurement changes in leg length and joint offset.

Implanet received global regulatory clearance for the Jazz Frame®, a system of connectors for use with JAZZ Band® technology in the treatment of spinal deformity. Launch is scheduled for 1Q17.

7D Surgical received regulatory clearance in the U.S. and Canada to market MvIGS™, the Machine-vision Image Guided Surgery system for spinal procedures.

Camber Spine Technologies received FDA 510(k) clearance for the Siconus™ SI Joint Fixation System for the treatment of sacroiliac disease.

Amplitude Surgical received FDA 510(k) clearance to market the Anatomic® implant for the treatment of degenerative knee disease.

The following 18 companies received their first FDA 510(k) in 2016. Whats interesting is that some companies like CG Bio, Meril Life Sciences and Overmed were founded in 2006a decade ago. Another, such as Onkos Surgical, was founded as recently as 2015.

Orthofix reached final resolutions of two previously-disclosed SEC investigations and agreed to pay ~US $14.0MM to settle charges regarding historic accounting matters and anti-bribery matters in Brazil. 

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. 

CyMedica Orthopedics received FDA 510(k) clearance for e-vive™, an app-controlled, data-driven muscle activation therapy and patient engagement solution for ACL and total knee replacement patients.

SpineGuard received FDA 510(k) clearance to integrate the DSG™ technology with Zavation's pedicle screws.

Whale Imaging received FDA 510(k) clearance of G-Arm® B6 Duo, next-gen bi-plane surgical imaging technology with features such as axial tilt and greater table access.

Zimmer Biomet (ZBH) concluded agreements with the U.S. DOJ and SEC to resolve previously-disclosed matters involving Biomet. A $30.5MM payment from ZBH has already been recorded in financial statements and will not impact 2017 guidance.

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)

Medicrea filed its FDA 510(k) submission for 3D-printed titanium interbody devices with compatible UNiD™ Lab surgical planning and analytical services. 

Orthofix announced U.S. FDA premarket and European CE Mark approval for next-gen CervicalStim™ and SpinalStim™ bone growth stimulators.

Globus Medical received CE Mark approval for the Excelsius GPS™ robotic trajectory guidance and navigation system. 

Corin was awarded a 5A* ODEP rating from the Orthopaedic Data Evaluation Panel for its MiniHip™ bone conserving hip, MetaFix™  collarless cementless total hip and the Trinity™ advanced bearing acetabular system.

FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors.

NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure.

Precision Spine received FDA 510(k) clearance for the AccuFit® Lateral Plating System.

Lima Corporate was awarded three new Orthopaedic Data Evaluation Panel ratings for hip implants in the U.K. The ratings are intended to indicate that a device's clinical performance falls in line with National Institute for Health and Care Excellence guidelines for implant survivorship.

Intrinsic Therapeutics filed a Premarket Approval application with FDA for the Barricaid® Anular Closure device. 

CartiHeal received FDA approval of its Investigational Device Exemption application submitted for the Agili-C™ implant, in support of a Premarket Approval application.

ZipLine Medical received China Food and Drug Administration approval of its Zip® Surgical Skin Closure device. 

Anika Therapeutics received CE Mark approval for ORTHOVISC®-T injection indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.

Amedica re-filed an application with FDA with a modified cancellous-structured ceramic (CsC)-based cervical implant that is comparable to the Valeo®C.

Safe Orthopaedics received approval under the CE Mark for a next-generation Oak pedicle screw for the treatment of thoracic vertebral fractures.

FDA approved Vericel's MACI® for the repair of adult symptomatic single or multiple full-thickness cartilage defects of the knee.

Zimmer Biomet reports that most product lines impacted by previously-disclosed shipping delays have returned to full shipping capacity, and disclosed the receipt of a Form 483 following an FDA inspection of a legacy Biomet manufacturing site in Warsaw, Indiana.

Strategic orthopaedic-related 510(k)s issued in November 2016 include: Preference Elite Pedicle Screw System (Amedica); Titanium Porous Fixation Device (Amorchem); Moss 100 Pedicle Screw System (Biedermann Motech); Persona Partial Knee (Biomet/Zimmer Biomet); AltiVate Anatomic Shoulder, Exprt Revision Hip (Encore Medical/DJO); Initia Total Hip & Bioceram AZUL Head (Kyocera Medical); Virtu C Spinal Implant (Met 1); Interference Screw (Nanova Biomaterials); Fortezza Spinal Stabilization System (Osso Surgical)

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. 

curasan received FDA 510(k) clearance to market CERASORB Ortho FOAM synthetic bone material for the treatment of bone defects in the extremities and pelvis. 

JRI Orthopaedics received regulatory approval in China and will supply 10,000 hips for distribution by AK Medical over a five-year term in a deal valued at minimum £5MM (~US $6.3MM).

The International Cartilage Repair Society launched what is claimed as the first global, web-based patient registry offering an international data pool for articular cartilage injury, history and treatment. 

Kyocera Medical received FDA 510(k) clearance for the Initia® Total Hip system, designed for use with BIOCERAM AZUL® zirconia-toughened alumina ceramic femoral heads.  

Xtant Medical announced FDA 510(k) clearance to market the Xsert™ Lumbar Expandable Interbody System. Initial product launch will commence in mid-2017.

Artoss announced FDA 510(k) clearance to market NanoBone® SBX Putty. 

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 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.

SeaSpine received FDA 510(k) clearance to market the Shoreline™ ACS Anterior Cervical Standalone system. Full commercial launch is slated for 1H17.

NuVasive received FDA clearance for magnetic resonance imaging under certain conditions on patients treated with the MAGEC® growth modulation 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.

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.

SIGNUS Medizintechnik announced FDA 510(k) clearance to market the DIPLOMAT® pedicle screw system. 

Medicrea received FDA 510(k) clearances for its PASS® XS posterior fixation and LigaPASS® XS band connector components, designed to address spinal deformities in small stature patients.

CollPlant received CE Mark approval for Vergenix™STR soft tissue repair matrix for the treatment of tendinopathy. EU launch is anticipated in coming months.

Strategic orthopaedic-related 510(k)s issued in September 2016 include: Bone Wedge System (Additive Orthopaedics); Portage System - Arthroscope (Baylis Medical); Spinal Fixation System (Canwell Medical); Interform Cervical Interbody Cage (Next Orthosurgical); MAGEC Spinal Bracing and Distraction System (NuVasive Specialized Orthopedics); K-Wire and Pin System (Syntorr); mi-eye 2 Arthroscope (Trice Medical)

Spineology received FDA 510(k) clearance for use of allograft bone with Rampart™ Interbody Fusion Devices.

K2M received FDA 510(k) clearance for additional implant sizes of its CASCADIA™ Lateral Interbody System. 

AxioMed received approval from the Therapeutic Goods Administration to market cervical and lumbar Freedom Viscoelastic Disc Replacement devices in Australia.

Regentis Biomaterials received FDA Investigational Device Exemption approval to initiate a pivotal Phase III clinical study of its GelrinC procedure to treat focal knee cartilage defects.

joimax's TESSYS® transforaminal and iLESSYS® interlaminar procedures are fully covered in the U.S. following release of a new CPT 2017 Codebook by the American Medical Association. 

In 1H16, 21 companies received their first orthopaedic-related 510(k). Of these, ten were bestowed for spinal products. Of those ten companies, only four are slated to appear on the NASS floor this year.

K2M received FDA 510(k) clearance for components for the MESA® Spinal System, supporting use as part of a growing rod construct to accommodate growth in patients under 10 years old.

Life Spine received FDA 510(k) clearance to market the PRO-LINK® Ti Standalone Cervical Spacer. Full launch is scheduled for the end of 4Q16.

RTI Surgical received regulatory clearance for nanOss® Bioactive bone void filler in Australia, as well as CE Mark for nanOss Bioactive Loaded and nanOss Bioactive 3D in Europe. 

NuVasive Specialized Orthopedics received FDA 510(k) clearance to market the MAGEC® system for treatment of severe spinal deformity.

Meditech Spine received FDA 510(k) clearance to market CURE Anterior Cervical Plates to complement its Talos®-C (HA) interbody devices.

Strategic orthopaedic-related 510(k)s issued in August 2016 include: Xycor Expandable Spinal Spacer (Alphatec Spine); Valeo II Interbody Fusion Device (Amedica); Tarsa-Link Standalone Wedge, Hammertoe Correction System (Centric Medical/Life Spine); Universal Spine System (Double Medical Technology); Titan Reverse Shoulder (Integra LifeSciences); Virtu Lumbar Spacer (Met 1 Technologies*); Distal Radius Plating System (Miami Device Solutions); Response BandLoc Spinal Fixation (OrthoPediatrics)

Carestream Health received FDA 510(k) clearance for the OnSight 3D Extremity System to capture weight-bearing and other types of extremity exams.

Additive Orthopaedics received FDA 510(k) clearance for its 3D-printed osteotomy wedge to address fractures or osteotomies in the foot and ankle. 

Vexim received approval in Australia to market SpineJack® and the Masterflow™ cement delivery system. Product is slated for initial export within 2016.

Amedica received FDA 510(k) clearance for expanded sizes of the Valeo® II Lateral Lumbar interbody fusion device.

Centric Medical announced FDA 510(k) clearance of the TARSA-LINK™ Bunion Correction system, reported to be the first-to-market standalone opening base wedge to feature built-in fixation. Launch is slated for 4Q16.

Conventus Orthopaedics received FDA 510(k) clearance to market Conventus Cage™ DU (Distal Ulna) and PU (Proximal Ulna) systems for fracture repair.

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)

Centric Medical received FDA 510(k) clearance to market its Hammertoe Correction System. Market launch will occur at the end of 3Q16.

4WEB Medical received FDA 510(k) clearance to market its Lateral Spine Truss interbody fusion device.

Medtronic received FDA 510(k) clearance to market the CD Horizon® Fenestrated Screw Set, indicated for treatment of advanced stage tumors in the thoracic and lumbar spine.

NeuroPro Spinal Jaxx received FDA 510(k) clearance to market the Spinal Jaxx expandable intervertebral spacer.

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. Product introduction will occur within 7/16.

Cytori Therapeutics announced approval for Cytori Cell Therapy™ under the Japanese Act on the Safety of Regenerative Medicine. 

Centric Medical received FDA 510(k) clearance to market the Subtalar Arthroereisis Implant. Limited release will occur at the end of 2016, with full launch following in 1Q17.

Centinel Spine received regulatory clearance in Australia for the STALIF L™ No-Profile, Lateral Lumbar Integrated Interbody system.

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.

SpineGuard received FDA 510(k) clearance to market the PediGuard Threaded DSG™ device for Dynamic Surgical Guidance in pedicle screw insertion.

Tyber Medical received FDA 510(k) clearance of its headed and snap-off screws with configurations incorporating the proprietary BioTy™ modified surface treatment.

KB Medical received approval under the CE Mark for its AQrate™ Robotic Assistance system, indicated for use in general spinal surgery. 

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 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 submitted its responses to FDA in relation to the CASCADE clinical trial, and expects a final determination from FDA within 60 days. 

Amplitude Surgical filed for FDA 510(k) clearance of its posterior stabilized ANATOMIC® knee prosthesis.

Corin received FDA 510(k) clearance to market the Optimized Positioning System (OPS™), reportedly the first FDA-cleared technology to support functional, patient-specific component alignment in total hip replacement.

Avitus Orthopaedics launched pilot sales of the Avitus™ Bone Harvester.

MX Orthopedics received FDA 510(k) clearance to market the dynaMX™ Nitinol Compression Screw.

On 5/31/16, Zimmer Biomet received an FDA Warning Letter regarding observed non-conformities at the company's Zimmer CAS/ORTHOsoft facility in Montreal, Quebec, Canada.

Eden Spine received CE Mark approval for the SPHYNX™ titanium plate to treat thoracolumbar instability.

First Ray received FDA 510(k) clearance to market the SpeedButton™ system for attachment of soft tissue to bone.

K2M received FDA 510(k) clearances to market CASCADIA™ Cervical and CASCADIA AN Lordotic Oblique Interbody systems, featuring Lamellar 3D-printed Titanium Technology™.

Tyber Medical's interbody spinal device line has been accepted into the Australian Registry of Therapeutic Goods. Private label partners are slated to launch products in 3Q16. 

Ortho Kinematics received Health Canada approval for its lead product, Vertebral Motion Analysis, a diagnostic test for the assessment of spinal motion and radiographic instability.

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. 

Implanet received FDA 510(k) clearance and CE Mark approval for the Jazz Claw®, a hybrid implant designed to treat degenerative spinal pathologies.

Orthofix announced FDA 510(k) clearance and U.S. limited launch of the FORZA® PTC™ (Peek Titanium Composite) Spacer.

First Ray received FDA 510(k) clearance for the CortiClamp™ System for small bone fixation. 

Xtant Medical received FDA 510(k) clearance of a posterior cervical screw indication for the Certex® Spinal Fixation system.

Strategic orthopaedic-related 510(k)s issued in April 2016 include: Olympic Posterior Spinal Fixation System (Astura Medical); Revival Modular Revision Hip Stem (Corin); Internal Bone Staple, Bicortical Fixation Screw & Washer Nut System (First Ray*); G3 Active Plate Small Fragment System (Genesis Fracture Care); Maxigen Bone Void Filler (Hans Biomed); Osteopal Plus Bone Cement (Heraeus); Pedicle Screw System (icotec); Revolution Spinal Fixation System (Intelligent Implant); Glenoid Positioning System (Materialise); Ultra Telescope (Olympus Winter); White Pearl Preferred Angle Anterior Cervical Plate (Osseus Fusion); Starfuse Interphalangeal Pin, Osteobullet Compression Screw (Phalanx Innovations*) (View the full list of orthopaedic 510(k)s for April 2016) 

OrthoPediatrics received Japan regulatory clearance for RESPONSE™ Spine for use in pediatric and adult patients. The product will be distributed regionally through an exclusive agreement with Robert Reid. 

Camber Spine Technologies received FDA 510(k) clearance to market the ENZA™ Zero Profile Anterior Interbody Fusion system.

Orthocell was granted ethical approval in Australia for a clinical study of a microfracture technique using the Celgro SMRT Graft collagen scaffold.

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.

Medicrea received FDA clearance to market what is reported to be the first-ever patient-specific cervical rod for spine surgery, the UNiD™ Cervical rod.

Exactech received FDA 510(k) clearance to market the Vantage™ Total Ankle. Targeted clinical evaluation will commence in mid-2016, with full launch slated for 1Q17.

FDA's Orthopaedic and Rehabilitation Devices Panel recommended premarket approval of Cartiva's Synthetic Cartilage Implant for the treatment of osteoarthritis in the great toe.

Ortho Kinematics received CE Mark approval for its Vertebral Motion Analysis (VMA) technology. Commercialization will begin in the U.K. during 2016.

Strategic orthopaedic-related 510(k)s issued in March 2016 include: Vantage Total Ankle (Exactech), Align Anterior Ankle Fusion Plate (Extremity Medical), Jazz Lock (Implanet), PROLIFT Expandable Interbody System (Life Spine), OrthAlign Plus UniAlign (OrthAlign), Tesera SC Standalone Anterior Cervical Plate (Renovis Surgical), S-Wire (Spinal Resources), Interbody System (Surgtech), Xspan Laminoplasty Fixation System (X-spine/Xtant Medical) (View the full list of orthopaedic 510(k)s for March 2016)

EOS imaging received FDA clearance to market spineEOS, online 3D planning software for spine surgery based on stereo-radiographic 2D/3D imaging. 

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.

Implanet received FDA 510(k) clearance and CE Mark approval for Jazz Lock®, a band-shaped implant to treat degenerative spinal disorders, including cervical. Commercial launch is underway.

ConforMIS withdrew its FDA 510(k) application for the iTotal Hip device, and plans to submit a new application in 2H16.

Renovis Surgical received FDA 510(k) clearance to market the Tesera™ SC porous titanium cervical interbody fusion system.

Xtant Medical received FDA 510(k) clearance to market the Xspan™ Laminoplasty Fixation system. Initial limited launch is slated for 2Q16. 

Extremity Medical received FDA 510(k) clearance to market the Align Ankle Fusion System™. Initial launch is slated for mid-April 2016. 

Tenex Health received FDA 510(k) clearance to market the TX2 MicroTip, with application to treat tendinosis of the shoulder and hip in an outpatient procedure. Launch is slated for mid-2016. 

Anika Therapeutics received CE Mark approval for CINGAL® as a medical device to treat knee osteoarthritis pain. 

Results from a 6-month study observing BioElectronics' ActiPatch® musculoskeletal pain therapy device indicated an average 61% reduction in pain for >90% of participants, a decrease in doctor visits, etc. 

Carestream Health filed its FDA 510(k) application for the CARESTREAM OnSight 3D system for weight-bearing extremity imaging.

EOS imaging received regulatory approval to market the EOS 2D/3D orthopaedic imaging system in China.

BioPoly received approval under the CE Mark for the BioPoly® RS Partial Resurfacing Shoulder. 

FDA is proposing to classify posterior cervical screw systems into Class II (special controls) and to continue to require premarket notification for the devices.

Strategic orthopaedic-related 510(k)s issued in February 2016 include: C-VBR (Cardinal Spine), Lateral Interbody System (Cogent Spine), M-Fix Acromioclavicular Device (Coracoid Solutions*), Extremity Plate System (Epic Extremity), Winch Kyphoplasty Gauge (G21), MiniARS Screws (Overmed*), Irene Locking Compression Plate (Tianjin Zhengtian Medical Instrument*), trauma Screw (Tyber Medical), Comprehensive SRS/Nexel Elbow (Zimmer Biomet)

NuVasive received regulatory approval for ReLine™ posterior fixation technology in Japan. Launch will commence later in 2016 and continue into 2017. 

Life Spine received FDA 510(k) clearance to market the PROLIFT® Expandable Interbody System for use in minimally invasive PLIF, TLIF and oblique approaches.

FDA has accepted for filing Vericel's BLA for MACI™, matrix-applied characterized autologous cultured chondrocytes intended to treat adult symptomatic knee cartilage defects.

Stryker Spine announced FDA 510(k) clearance of Tritanium® PL, a highly-porous posterior lumbar cage manufactured via 3D additive manufacturing. Launch will occur in 2Q16.

Zimmer Biomet (ZBH) received FDA 510(k) clearance for compatibility of the Nexel™ Total Elbow with the Comprehensive® Segmental Revision System. This marks the 1st submission by ZBH to establish compatibility of two separate ZBH implant systems. 

Xtant Medical received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.

OrthAlign received FDA 510(k) clearance to market UniAlign™, a handheld, single-use navigation device for Unicompartmental Knee Arthroplasty. 

Tyber Medical received FDA 510(k) clearance of BioTy™ Modified Surface Treatment for use on its Headless Screw system, and expanded its exclusive licensing agreement to further enhance BioTy proprietary technology and IP.

Cardinal Spine received FDA 510(k) clearance for the C-VBR cervical vertebral body replacement, reportedly the 2nd cervical VBR to be cleared by FDA and the 1st such device designed with no possibility of reduction in height after surgery.

EOS imaging received CE Mark approval for spineEOS, online 3D planning software based on bi-planar imaging.

Preliminary study results indicate that the Vital 5 ReLeaf Catheter improved pain scores and reduced post-op narcotic use following orthopaedic and spinal surgeries, and may support a transition to outpatient procedures.

Study findings demonstrate a statistically significant reduction in bacteria on implant surfaces processed with Tyber Medical's BioTy™ Modified Surface Treatment.

FDA issued a final order requiring OEMs to submit a premarket approval application for certain metal-on-metal total hip replacement devices.

On 2/19/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Medtronic's DIAM™ Spinal Stabilization System. 

National Government Services issued a positive local coverage determination for MIS SI joint fusion, including SI-BONE's iFuse procedure, effective 4/1/16.

Zimmer Biomet received FDA 510(k) clearance for the Unite3D™ Bridge Fixation System, 3D-printed technology designed for use in foot and ankle arthrodesis.

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 received FDA 510(k) clearance to market VariLift®-LX as a lumbar interbody fusion device for standalone use.

MX Orthopedics received FDA 510(k) clearance to market the dynaMX™ Compression Staple, a superelastic Nitinol-based device. 

FDA tentatively scheduled a 2Q16 meeting of the Orthopaedic and Rehabilitation Devices Panel to review Cartiva's Premarket Approval Application for the Synthetic Cartilage Implant in the treatment of great toe osteoarthritis.

In late 2015, FDA assigned Anika Therapeutics' CINGAL to the Center for Drug Evaluation and Research (CDER) and not the Center for Device and Radiological Health (CDRH) for its premarket review-a decision with which Anika's leadership says it disagrees.

K2M's RHINE™ Cervical Disc has received approval under the CE Mark. 

Centinel Spine received FDA 510(k) clearance to market the ALTOS™ posterior cervical thoracic stabilization system.

Episurf Medical received CE Mark approval for the Epioscopy™ Damage Assessment Tool, designed to support 3D visualization of knee segments, visual marking of lesions and a written assessment of structural deviations on the tibia, patella, meniscus and ACL.

Strategic orthopaedic-related 510(k)s issued in December 2015 include: Fusion Implant System (Bio2 Technologies), Spinal Fixation System (Changzhou Dingjian Medical), Metallic Intramedullary Nail (Changzhou Waston Medical), Latitude-C Cervical Interbody Spacer (DeGen Medical), V-Steady and V-Fast Bone Cements (G21), Firefly Pedicle Screw Navigational Guide (Mighty Oak Medical), Apex Revision Knee (OMNIlife sciences), Remedy Shoulder Spacer (Osteoremedies), Internal Joint Stabilizer, Elbow (Skeletal Dynamics) 

Bio2 Technologies received FDA 510(k) clearance to market a fusion system for interphalangeal fusion, fracture repair and osteotomies of toes, fingers and other small bones. Limited product launch is slated for 2Q16.

Intellijoint Surgical received FDA 510(k) clearance to market the next-generation intellijioint HIP™ surgical smart tool, now including cup position (inclination and anteversion).

MEDTECH received FDA 510(k) clearance to market the ROSA™ Spine robot assistive system for use in minimally invasive surgical procedures.

Vericel submitted a Biologics License Application to FDA for MACI™ matrix applied characterized autologous cultured chondrocytes, an investigational product intended to treat adult symptomatic cartilage defects of the knee.