FDA 510(k) Recap: First Clearances for Companies in Spine and Trauma
Get to know products from BoxSpine, Chest Wall Innovations, Reselute, Satori Orthopaedics, and SpinePoint. ...
Jun 03 2026,
Products
Zimmer Biomet Earns 510(k) for Updated ROSA Shoulder System
The updated system offers robotically assisted glenoid reaming and humeral resection with the ability to support robotic anatomic and...
May 27 2026,
Stryker Launches Pangea Plating System in Europe
The system includes complementary instrumentation to support plate fit and provide options for fracture fixation across the upper and lower...
May 26 2026,
SpineCraft Earns 510(k) for ORIO-3D Trabecular Interbody Platform
The comprehensive portfolio of trabecular 3D-printed titanium implants is designed to support spinal fusion for various surgical approaches....
May 12 2026,
ArthroTAK Granted 510(k) for ArthroTAK Tendon Anchor Kit
The system eliminates the need for sutures, suture passers, knot-tying, or power equipment, reducing surgical complexity and procedural time....
May 05 2026,
FDA 510(k) Clearance for FX V135 Easytech Shoulder System
FX Shoulder Solutions' design enables surgeons to begin with a stemless approach and transition intraoperatively to a short stem solution...
May 05 2026,
Foundation Surgical Earns 510(k) for Navigated Lateral Disc Preparation Instruments
The platform is compatible with established technologies, including Medtronic’s O-Arm imaging system and StealthStation navigation platform....
Apr 17 2026,
Zimmer Biomet Gains FDA Clearance for Expanded Reverse Shoulders
New Identity and Comprehensive Reverse shoulders offer smaller components and tools developed with smaller patient anatomy in mind....
Apr 17 2026,
FDA Recap: Newer Players Offer Novel Devices
In this edition of the 510(k) recap, we highlight three newer companies on the scene: Allevion Medical, Native Orthopaedics and...
Apr 08 2026,
Medacta Extends MyImplant Platform to Complex Hip Recon
The system offers a custom-fit solution developed to manage complex cases, particularly in situations where fixation may be challenging due...
Apr 02 2026,
SpinePoint Receives FDA Clearance for Flex-Z Cervical Cage
Built from 3D-printed porous titanium, Flex-Z is engineered to match cancelous bone stiffness in anterior cervical fusion....
Mar 27 2026,
FDA 510(k) Recap: Hardware, Software and Biologics for Spine
This month’s round-up includes three companies entering the space: Biomendex, McNicoll Surgical and SYNC Surgical. ...
Mar 10 2026,
Orthofix Launches Fitbone Trochanteric Lengthening System in the US
This product expansion introduces a trochanteric entry option designed to support both adult and pediatric patients....
Mar 04 2026,
Stryker Launches Triathlon Gold Femoral Component
The device is Stryker's first commercially available femoral component designed as an option for patients with metal sensitivity concerns....
Mar 03 2026,
DePuy Synthes Introduces VELYS Trauma AI-Assisted Surgery
VELYS Trauma AI-Assisted Surgery is designed to offer precise 3D guidance without trackers or reference bodies. ...
Mar 03 2026,