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Zimmer Biomet Receives FDA's 510(k) Clearance For ROSA Shoulder System
(RTTNews) - Medical technology firm Zimmer Biomet Holdings, Inc. (ZBH) announced Thursday the 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 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.
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