Zimmer Biomet Granted 510(k) for OsseoFit Stemless Shoulder

Zimmer Biomet received FDA 510(k) clearance to market the OsseoFit Stemless Shoulder System for total shoulder replacement. The system will be commercially available in 1Q25.

The implant is designed to match the natural humeral anatomy to optimize anatomical fit while maximizing preservation of healthy bone. OsseoFit Stemless integrates with Identity Humeral Heads with Versa-Dial Technology for infinite offset placement as well as the Alliance Glenoid for a range of glenoid options to adapt to a patient’s anatomy.

The anatomically designed left- or right-sided anchor implants feature fins which create a press-fit during insertion and contain fully porous windows. The fin geometry and anchor spacing of the implant determine proper orientation and fit into the natural bone and help avoid cortical impingement, while reaching dense bone areas.

In addition, the design includes strategically located anterior reattachment suture holes on the anchor to facilitate subscapularis repair. The system is available in a singular instrument tray to maximize workflow, suitable for ambulatory surgical centers.

“The OsseoFit Stemless Shoulder System combines an anatomically shaped implant which supports bone conservation and is designed for stable initial fixation, with our proprietary OsseoTi Porous Metal Technology for biological fixation,” said Brian Hatcher, President, SET & CMFT at Zimmer Biomet. “We are pleased to offer OsseoFit within our robust shoulder portfolio that includes modular, compatible components which provide surgeons with a multitude of options based on patients’ unique anatomy while maintaining a small instrument footprint and maximizing workflow efficiency.”

Source: Zimmer Biomet