Zimmer Biomet
(NYSE: ZBH)
announced today that it received FDA 510(k) clearance for its Rosa Shoulder robotic assisted surgery system.
The company says this marks the clearance of the world’s first robotic surgery system for shoulder replacement. It’s also the fourth application for the Rosa portfolio, which includes the Rosa Knee and Rosa Hip.
Zimmer Biomet said in a news release that Rosa Shoulder strengthens its shoulder implant portfolio. That includes the Identity Shoulder system and joins the ZBEdge Dynamic Intelligence platform. ZBEdge enhances the company’s digital technologies, robotics and implant solutions.
The company designed Rosa Shoulder to give surgeons the flexibility to execute total shoulder replacement using anatomic or reverse techniques. It enables precise placement for improved outcomes. According to Zimmer Biomet, it’s one of the only systems that can reproduce humeral head resectioning and ease insertion of instruments into incisions by requiring no pin in the center of the glenoid during procedures.
As with other Rosa applications, the system supports data-informed physician decision-making based on unique anatomies. It integrates with the newly released Signature ONE surgical planning system. Signature ONE uses a 3D image-based approach to visualization, surgical planning and patient-specific guide creation.
During the surgery, Zimmer Biomet’s platform provides real-time, intraoperative data to help control, execute and validate personalized plans.
The company plans to launch Rosa Shoulder in the U.S. in the second half of 2024.
“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, Zimmer Biomet president and CEO. “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.”