FDA Approves Zimmer Biomet’s Innovative Stemless Shoulder Solution

Zimmer Biomet (NYSE: ZBH) recently announced its new approval from the FDA for their OsseoFit stemless shoulder system meant for total shoulder arthroplasty.

Situated in Warsaw, Indiana, Zimmer Biomet crafted this implant to match the humeral bone’s natural contour. The design aims to enhance anatomical alignment while ensuring the conservation of healthy bone tissue. The OsseoFit system broadens the company’s array of total shoulder solutions and pairs seamlessly with Identity humeral heads, utilizing Versa-Dial technology for limitless offset adjustments. Furthermore, it integrates with the Alliance glenoid, offering numerous glenoid configurations tailored to a patient’s distinctive anatomy.

Dr. John W. Sperling, from Mayo Clinic, plays a pivotal role in the development team for the OsseoFit system. He emphasized the importance of bone preservation, especially as younger, active patients increasingly require shoulder replacements.

The implant’s design caters to both left and right shoulders, featuring fins that achieve a secure fitting upon insertion, alongside fully porous sections. This innovative fin structure and anchor distribution ensure correct alignment with the natural bone, minimizing cortical interference while targeting dense bone sections.

Moreover, the implant’s layout includes intentionally positioned anterior reattachment suture points to facilitate subscapularis repairs. Zimmer Biomet has carefully crafted the system’s single instrument tray to enhance operational efficiency and ensure sterile processes, suitable for various environments, including outpatient surgical centers.

The official rollout for this system is slated for the first quarter of 2025.

“We are delighted to add OsseoFit to our extensive shoulder range, providing surgeons with adaptable, modular components tailored to account for patients’ individual anatomical needs, while maintaining a streamlined instrument footprint and optimizing workflow,” noted Brian Hatcher, President, SET & CMFT at Zimmer Biomet.