Maxx Orthopedics Granted 510(k) for Libertas Bipolar Hip
Designed for use with 28mm femoral heads, the system delivers a reproducible solution for fracture management, osteonecrosis, and revision hip...
Nov 17 2025,
Products
Zimmer Biomet Earns 510(k) Clearance for Enhanced ROSA Knee
ROSA Knee with OptimiZe offers personalized surgical planning and drives confidence in delivering accurate and reproducible outcomes....
Nov 14 2025,
FDA 510(k) Recap: Advancements Across the Major Market Segments
Startups and small familiar companies take the spotlight in this month’s recap, including an approach to head off bacterial contamination,...
Oct 29 2025,
ALLUMIN8 Gains FDA 510(k) for A8 INTEGR8 Pedicle Screw
The system represents the first 5.5mm diameter pedicle screw produced through additive manufacturing....
Oct 22 2025,
Zimmer Biomet Gains PMDA Approval of Iodine-Treated Total Hip
The iTaperloc Complete and iG7 Hip System with Iodine Technology inhibits bacterial adhesion and prevents biofilm formation on the implant...
Sep 26 2025,
FDA 510(k) Recap: Fixation, Fusion and Field-of-View Navigation for Spine
We review cleared systems from Eminent Spine, SiVantage and Brainlab for application in the spinal segment....
Sep 24 2025,
Full Commercial Launch of the InSet 70 Humeral Stem
Shoulder Innovations' InSet 70 addresses osteoarthritis and avascular necrosis, rheumatoid and traumatic arthritis, and correction of functional deformity....
Sep 22 2025,
Ruthless Spine Gains 510(k) for NavJam Jamshidi Device
The device is designed to work in tandem with Ruthless Spine's De Novo cleared RJB intraoperative angle measurement instrument....
Sep 18 2025,
Stryker Launches Incompass Total Ankle System
Incompass was developed to mimic Stryker’s Infinity and Inbone with a similar implant profile, fixation and sulcus articulation. ...
Sep 09 2025,
First Surgery with Interwedge Standalone Lateral Implant
Foundation Surgical's Interwedge is designed to provide surgeons with a versatile standalone option for lateral interbody fusion procedures....
Sep 09 2025,
First US Patient Enrolled in BioPoly Partial Resurfacing Knee Clinical Trial
Instead of replacing the entire joint, BioPoly replaces only the damaged portion, thus preserving the patient’s natural joint tissue....
Sep 05 2025,
FDA 510(k) Recap: Clearances in Spine, Sports Medicine and Obio
Arthrex, SurGenTec and Wenzel Spine gained clearances that build on their established products or offer a new slant on technology....
Sep 03 2025,
Highridge Medical Acquires Spinal Products from Accelus
Acquired lines include the FlareHawk and Toro expandable interbody fusion systems, as well as the LineSider pedicle screw....
Sep 02 2025,
Full Commercial Release of Catalyst OrthoScience Fracture Shoulder
The Catalyst Fracture Shoulder System is designed to improve reverse shoulder arthroplasty for proximal humeral fractures....
Aug 13 2025,
ulrich medical USA Launches Cortium Universal OCT Spinal Fixation
Cortium is a comprehensive posterior system that allows surgeons to address complex spinal pathologies with control, flexibility and efficiency....
Aug 07 2025,