Zimmer Biomet has received clearance from the US Food and Drug Administration (FDA) under the 510(k) pathway for its OsseoFit Stemless Shoulder System.
The system is intended for use in total shoulder replacement procedures and is designed to align with the natural anatomy of the humerus while preserving bone during implantation.
The company stated that the OsseoFit Stemless Shoulder System expands its existing range of total shoulder implants. It is compatible with Zimmer Biomet’s Identity Humeral Heads, which incorporate Versa-Dial Technology, allowing for infinite offset placement.
The system can also be used alongside the Alliance Glenoid, the company’s anatomical glenoid replacement product, to align with the unique requirements of individual patients.
Zimmer Biomet president Brian Hatcher said: “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.
“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 maximising workflow efficiency.”
The system includes implants designed for either the left or right shoulder. These implants feature fins that allow for a press-fit insertion process.
Zimmer Biomet highlighted that the specific geometry and spacing of the fins ensure that the implant aligns properly with the bone, avoiding cortical impingement and targeting dense bone areas for stability. The implants also include suture holes positioned to assist with subscapularis repair during the procedure.
Zimmer Biomet confirmed plans to commercialise the OsseoFit Stemless Shoulder System in the first quarter of 2025.
The system will be supplied in a single instrument tray, which the company indicated is intended to streamline workflows and meet the needs of different surgical settings, including ambulatory surgical centres.
Mayo Clinic orthopaedic surgery professor and OsseoFit Stemless Shoulder System surgeon development team member John Sperling said: “As younger and more active patients require shoulder replacements; bone preservation becomes increasingly critical to accommodate potential revision procedures in the future.
“Using a method that mimics the asymmetry of the natural humerus enables surgeons to preserve native bone while optimising fixation.”
