"World's first" robotic surgery system for shoulder replacement cleared by FDA

Zimmer Biomet has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.

Zimmer says ROSA Shoulder is the world's first robotic surgery system for shoulder replacement, and the fourth application for its 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 shoulder implant portfolio, which includes the Identity Shoulder System, and joins ZBEdge Dynamic Intelligence.

Ivan Tornos, president and chief executive officer at Zimmer Biomet, said: "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. 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 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 centre 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 visualisation, 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 personalised plans for glenoid and humeral placement, with a goal to reduce complications for patients.

John W. Sperling, MD, MBA, professor of orthopaedic surgery at Mayo Clinic, said: "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. 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."

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.