Zimmer Biomet obtains FDA 510(k) clearance for its ROSA® Shoulder System

Zimmer Biomet Holdings, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for the ROSA® Shoulder System, a robotic-assisted technology for shoulder replacement surgery. This marks a significant advancement as ROSA Shoulder is the world’s pioneering robotic surgery system for shoulder replacement, expanding the company’s comprehensive ROSA® Robotics portfolio, which already includes systems for total knee arthroplasty (ROSA® Knee System) and total hip replacement (ROSA® Hip System).

The addition of ROSA Shoulder enhances Zimmer Biomet’s innovative shoulder implant lineup, including the Identity Shoulder System. It integrates with ZBEdge™ Dynamic Intelligence™, a powerful tool leveraging cutting-edge digital technologies, robotics, and implant solutions.

“We are proud and excited to be the first company in the world to deliver a robotic surgical assistant for anatomic and reverse shoulder replacement surgery,” said Ivan Tornos, President and Chief Executive Officer at Zimmer Biomet. “ROSA Shoulder represents a novel advancement intended to help surgeons leverage the power of robotics and data analytics to perform highly complex shoulder procedures with accuracy1 and efficiency.”

Designed to offer surgeons flexibility, ROSA Shoulder supports both anatomic and reverse techniques for total shoulder replacement, ensuring precise placement and improved outcomes. Notably, it is one of the few systems capable of replicating humeral head resectioning and facilitates instrument insertion without requiring a pin in the center of the glenoid during procedures. Like other ROSA Robotics applications, ROSA Shoulder aids data-informed decision-making based on a patient’s unique anatomy. Prior to surgery, it integrates with the Signature™ ONE Surgical Planning System 2.0, employing a 3-D image-based approach for visualization, planning, and creating patient-specific guides. During surgery, the platform provides real-time intra-operative data, empowering surgeons to control, execute, and validate personalized plans for glenoid and humeral placement, ultimately aiming to reduce complications.

“One of the challenging aspects of performing a shoulder replacement is accurate glenoid and humeral placement, which is a critical factor for post-operative function and long-term implant survival,” said John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic. “This innovative approach is designed to allow surgeons to virtually walk through a procedure before making any resections, and then receive live feedback and the ability to control glenoid ream depth and intra-operatively validate cut resections during the procedure.”

The commercially available ROSA Shoulder is set to launch in the U.S. in the second half of 2024, complementing the mymobility® Digital Care Management Platform within the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.

© Zimmer Biomet Holdings, Inc.

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