Zimmer Biomet Holdings has nabbed U.S. FDA 510(k) clearance for the ROSA Shoulder System, a robotic surgery system for shoulder replacement. It’s the fourth application in the ROSA Robotics portfolio, which also includes systems for knee and hip replacement surgeries. The ROSA Shoulder joins Zimmer Biomet’s existing shoulder implant offerings, such as the Identity Shoulder System and ZBEdge Dynamic Intelligence.
“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 accuracy and efficiency.”
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 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 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, intraoperative 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.
