Zimmer Biomet has gained 510(k) clearance from the US Food and Drug Administration (FDA) for the OsseoFit Stemless Shoulder System.
Designed for total shoulder replacement, the implant is tailored to preserve healthy bone while providing a fit that mirrors natural humeral anatomy.
OsseoFit is part of the company’s comprehensive total shoulder portfolio. It is compatible with Identity Humeral Heads with Versa-Dial Technology, enabling infinite offset placement, and the Alliance Glenoid, offering a wide range of options to suit individual patient anatomy.
Designed for either the left or right side, the OsseoFit implants feature finned anchors that ensure a secure press-fit upon insertion.
Fin geometry and anchor spacing of the system are meticulously crafted to align with natural bone structures, for preventing cortical impingement and targeting dense bone areas. It also includes anterior suture holes on the anchor to aid in subscapularis repair.
The OsseoFit Stemless Shoulder System is intended to streamline surgical workflow and sterile processing efficiency.
Available in a single instrument tray, the system is suitable for various healthcare settings, including ambulatory surgical centres. The commercial availability of the system is expected in the first quarter of next year.
Zimmer Biomet SET and CMFT 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 the patient's unique anatomy while maintaining a small instrument footprint and maximising workflow efficiency."
Before this announcement, Zimmer Biomet also obtained 510(k) clearance for its Persona SoluTion porous plasma spray femur, a component of its total knee implant system.
