News
Zimmer Biomet Wins FDA Clearance for Stemless Shoulder Replacement System
- By John K. Waters
- 12/16/2024
Zimmer Biomet announced last week that it has received U.S. FDA 510(k) clearance for its OsseoFit Stemless Shoulder System, an implant designed to preserve healthy bone during total shoulder replacement procedures.
The OsseoFit system features an anatomically shaped, asymmetric design to match the natural structure of the humerus (upper shoulder bone), ensuring a better fit while minimizing bone loss. The product integrates with Zimmer Biomet’s Identity Humeral Heads and Alliance Glenoid components, offering flexibility for surgeons to address patients' unique anatomical needs.
Brian Hatcher, President of SET & CMFT at Zimmer Biomet, highlighted the innovation’s key focus areas. "The OsseoFit Stemless Shoulder System combines an anatomically shaped implant for bone conservation with our proprietary OsseoTi Porous Metal Technology to enhance biological fixation," Hatcher said in a statement.
The device's design includes left- and right-sided anchor implants with fin geometry to create a stable, press-fit fixation while avoiding cortical bone impingement. Strategically placed suture holes on the anchor further facilitate subscapularis repair, a crucial step in shoulder procedures. Additionally, the system is packaged in a single instrument tray to maximize workflow efficiency, making it suitable for both hospitals and outpatient surgical centers.
John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic and part of the OsseoFit development team, emphasized the significance of bone preservation for younger, active patients. "Using a method that mimics the natural humeral asymmetry allows surgeons to conserve native bone while optimizing fixation," he said.
Zimmer Biomet is a global medical technology company that designs, manufactures, and markets orthopedic reconstructive products, dental implants, spinal implants, and other surgical and biologic technologies. Headquartered in Warsaw, Indiana, USA, the company specializes in solutions that aim to restore mobility and improve the quality of life for patients suffering from musculoskeletal conditions.
The OsseoFit Stemless Shoulder System is expected to become commercially available in the first quarter of 2025.
About the Author
John K. Waters is the editor in chief of a number of Converge360.com sites, with a focus on high-end development, AI and future tech. He's been writing about cutting-edge technologies and culture of Silicon Valley for more than two decades, and he's written more than a dozen books. He also co-scripted the documentary film Silicon Valley: A 100 Year Renaissance, which aired on PBS. He can be reached at [email protected].