Zimmer Biomet has received the US Food and Drug Administration (FDA) 510(k) approval for the OsseoFit Stemless Shoulder System for total shoulder replacement.
The shoulder implant system is designed to match the natural anatomy of the humerus (bone of the upper extremity) to optimise anatomical fit while preserving healthy bone.
According to the US-based medical technology company, OsseoFit Stemless Shoulder System expands its extensive portfolio of total shoulder implants.
The system integrates with the company’s Identity Humeral Heads with Versa-Dial Technology for infinite offset placement.
Also, it can be used with Alliance Glenoid, the company’s anatomic glenoid replacement system to conform with the patient’s unique anatomy, said Zimmer Biomet.
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 OsseoFit Stemless Shoulder System comes with anatomically designed left- or right-sided anchor implants with fins that enable a press-fit during insertion.
The fin geometry and anchor spacing of the implant ensure 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.
Zimmer Biomet intends to commercialise the OsseoFit Stemless Shoulder system in the first quarter (Q1) of 2025.
The company will offer the system in a singular instrument tray to maximise workflow, and sterile process efficiency, to address different 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.”
Recently, Zimmer Biomet received US FDA 510(k) clearance for Persona SoluTion Porous Plasma Spray (PPS) Femur knee implant component.
