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Zimmer Biomet Holdings, Inc., a global medical technology leader, announced US Food and Drug Administration (FDA) 510(k) clearance for the OsseoFit Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to match the natural humeral (upper shoulder bone) anatomy to optimize anatomical fit while maximizing preservation of healthy bone. The OsseoFit Stemless Shoulder System expands the company's expansive total shoulder portfolio and integrates with Identity Humeral Heads with Versa-Dial Technology for infinite offset placement as well as the Alliance Glenoid for a broad range of glenoid options to adapt to a patient's unique anatomy.
"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."
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, and sterile process efficiency, to fit nicely in a variety of settings including ambulatory surgical centres.
"As younger and more active patients require shoulder replacements, bone preservation becomes increasingly critical to accommodate potential revision procedures in the future," said John W. Sperling, MD, MBA, Professor of Orthopaedic Surgery at Mayo Clinic, and a member of the OsseoFit Stemless Shoulder System surgeon development team. "Using a method that mimics the asymmetry of the natural humerus enables surgeons to preserve native bone while optimizing fixation."
The OsseoFit Stemless Shoulder will be commercially available in Q1 2025.
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health.
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