Regulatory

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

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.

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

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.

Regulatory Report: 42 Companies that Received their First Orthopedic-Related FDA 510(k) in 2018

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.

Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices

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)

Strategic orthopaedic-related 510(k)s issued in April 2017

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)

Strategic orthopaedic-related 510(k)s issued in February 2017

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*)

Strategic orthopaedic-related 510(k)s issued in January 2017

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)

LIMA CORPORATE Awarded New ODEP Ratings

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.

Strategic orthopaedic-related 510(k)s issued in November 2016

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)

Strategic Orthopaedic-related 510(k)s issued in September 2016

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)

Strategic Orthopaedic-related 510(k)s issued in August 2016

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)

Strategic Orthopaedic-related 510(k)s issued in July 2016

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)

Strategic Orthopaedic-related 510(k)s issued in May 2016

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*)

Strategic Orthopaedic-related 510(k)s issued in April 2016

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 Enters Japan Market

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. 

Strategic Orthopaedic-related 510(k)s issued in March 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)

Strategic Orthopaedic-related 510(k)s issued in February 2016

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)

Strategic Orthopaedic-related 510(k)s issued in January 2016

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*)

Strategic Orthopaedic-related 510(k)s issued in December 2015

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)