Zimmer Biomet has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OsseoFit stemless shoulder system for total shoulder replacement.

According to Zimmer Biomet, the implant was designed to match natural humeral anatomy to optimize anatomical fit while maximizing preservation of healthy bone. OsseoFit integrates with the company’s Identity humeral heads with Versa-Dial tech for infinite offset placement, as well as the Alliance glenoid for a broad range of options to adapt to a patient’s unique anatomy.

The anatomically designed left- or right-sided anchor implants have fins that create a press-fit during insertion and contain fully porous windows. The implant’s fin geometry and anchor spacing, according to Zimmer Biomet, determine proper fit into natural bone and help prevent cortical impingement.

The design also features strategically located anterior reattachment suture holes on the anchor to facilitate subcapularis repair. The system comes in a singular instrument tray.

“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 OsseoFit stemless shoulder will become commercially available in Q1 2025.

“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 Orthopedic 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.”