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.