Zimmer Biomet Holdings, Inc., a pioneer in medical technology worldwide, announced that their OsseoFit Stemless Shoulder System has received 510(k) clearance from the US Food and Drug Administration (FDA) for use in total shoulder replacement procedures. This state-of-the-art implant is engineered to complement the natural curvature of the humeral (upper arm) bone for an optimal fit while conserving healthy bone tissue. The introduction of the OsseoFit Stemless Shoulder System further broadens the company’s extensive portfolio of shoulder solutions, integrating seamlessly with Identity Humeral Heads featuring Versa-Dial Technology for limitless offset adaptations, along with the Alliance Glenoid to cater to individual anatomical requirements.
“The OsseoFit Stemless Shoulder System combines an anatomically configured implant aimed at preserving bone and ensuring initial stability, alongside our exclusive OsseoTi Porous Metal Technology for biological fixation,” stated Brian Hatcher, President of SET & CMFT at Zimmer Biomet. “We’re excited to include OsseoFit in our comprehensive range of shoulder solutions that feature modular and compatible components, enabling surgeons to tailor solutions according to each patient’s unique anatomy while maintaining a minimal instrument footprint and enhancing workflow efficiency.”
The anchors are anatomically contoured for left- or right-sided placement and include fins that achieve a press-fit upon insertion and have fully porous windows. The geometry and alignment of the fin and anchor are designed to ensure the implant fits correctly into the natural bone and minimizes cortical collisions while accessing dense bone regions. Additionally, the design includes anterior reattachment suture openings on the anchor to facilitate the repair of the subscapularis muscle. The system comes housed in a single instrument tray to boost workflow and sterilization efficiency, making it suitable for various settings, including outpatient surgery centers.
“The growing demand among younger, more active patients for shoulder replacements underscores the necessity for bone preservation, which is vital for future revision procedures,” commented John W. Sperling, MD, MBA, an Orthopaedic Surgery Professor at Mayo Clinic and participant in the OsseoFit Stemless Shoulder System’s surgeon development team. “Adopting a design that reflects the asymmetry of the natural humerus allows surgeons to conserve native bone while optimizing fixation.”
The OsseoFit Stemless Shoulder will launch commercially in the first quarter of 2025.
Zimmer Biomet continues to be a leader in international medical technology, offering a vast range of products designed to enhance mobility and promote wellness.