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.