510(k) Clearance

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.

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.

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.

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.

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.

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.

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

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.

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.

Artoss gained FDA 510(k) clearance to market NanoBone® SBX Putty for standalone use in posterolateral spinal fusion.

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.

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.

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.

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.

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.

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. 

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

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

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.

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

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.

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. 

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.

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. 

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

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.

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. 

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

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.

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.

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.

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.

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. 

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. 

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.  

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.

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.

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.

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

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.

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

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

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.

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

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

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)

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.

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.

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.

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.

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. 

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

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

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

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)

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. 

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. 

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

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.

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. 

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.

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. 

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 spac