Zimmer Biomet Holdings, Inc., a leading global medical technology company, has announced the US Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery. 

This approval marks a significant milestone as ROSA Shoulder becomes the world's first robotic surgery system designed specifically for shoulder replacement.

The ROSA Shoulder System joins Zimmer Biomet's comprehensive ROSA® Robotics portfolio, which includes the ROSA® Knee System for total knee arthroplasty and ROSA® Hip System for total hip replacement. This latest addition underscores Zimmer Biomet's commitment to innovation in orthopedic surgery and enhances its cutting-edge digital technologies, robotics, and implant solutions.

"We are thrilled to introduce the groundbreaking ROSA Shoulder System, the first-of-its-kind robotic surgical assistant for anatomic and reverse shoulder replacement surgery," stated Ivan Tornos, President and CEO at Zimmer Biomet. "This innovative advancement empowers surgeons with robotics and data analytics, enabling them to perform highly complex shoulder procedures with precision and efficiency."

The ROSA Shoulder System offers surgeons flexibility in executing total shoulder replacement using anatomic or reverse techniques, with a focus on precise placement for improved outcomes. Unique features include the ability to reproduce humeral head resectioning and facilitate instrument insertion without requiring a pin in the center of the glenoid during procedures. Moreover, ROSA Shoulder supports data-informed decision-making based on a patient's unique anatomy, integrating seamlessly with the newly released Signature™ ONE Surgical Planning System 2.0 for pre-operative visualization and planning.

Dr. John W. Sperling, Professor of Orthopedic Surgery at Mayo Clinic, highlighted the significance of ROSA Shoulder in addressing the challenge of accurate glenoid and humeral placement, critical for post-operative function and long-term implant survival. He praised the system's innovative approach, allowing surgeons to virtually simulate procedures before making resections and providing real-time feedback during surgery.

ROSA Shoulder is slated for commercial availability in the US in the second half of 2024 and will complement Zimmer Biomet's mymobility® Digital Care Management Platform, further enhancing the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.