Zimmer Biomet Holdings, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Shoulder System for robotic-assisted shoulder replacement surgery. ROSA Shoulder is the world's first robotic surgery system for shoulder replacement, and the fourth application for the Company's comprehensive ROSA® Robotics portfolio, which includes the ROSA® Knee System for total knee arthroplasty and ROSA® Hip System for total hip replacement. ROSA Shoulder strengthens Zimmer Biomet's innovative shoulder implant portfolio, which includes the Identity Shoulder System, and joins ZBEdge?

Dynamic Intelligence?, which has the power to enhance the company's cutting-edge digital technologies, robotics and implant solutions. ROSA Shoulder is designed to give surgeons the flexibility to execute a total shoulder replacement using anatomic or reverse techniques and to enable precise placement for improved outcomes. ROSA Shoulder is one of the only systems that can reproduce humeral head resectioning, and can ease insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures.

Like all ROSA Robotics applications, ROSA Shoulder is designed to support data-informed physician decision-making based on a patient's unique anatomy. Pre-operatively, ROSA Shoulder integrates with the newly released Signature? ONE Surgical Planning System 2.0, which uses a 3-D image-based approach to visualization, surgical planning and patient-specific guide creation.

During the surgery, the platform provides surgeons with real-time, intra-operative data to help them control, execute and validate personalized plans for glenoid and humeral placement, with a goal to reduce complications for patients. ROSA Shoulder will be commercially available in the U.S. in the second half of 2024, and will work with the mymobility® Digital Care Management Platform to bolster the ZBEdge Dynamic Intelligence portfolio for patients undergoing shoulder replacement surgery.