Zimmer Biomet Holdings has received FDA 510k clearance for its ROSE Shoulder System, a robotic-assisted shoulder replacement surgery. This is the company’s fourth application for the ROSA Robotics portfolio.
 
The ROSA Shoulder System is the first robotic system for shoulder replacement. It is designed for total shoulder replacements providing precise placement and using anatomic or reverse techniques. This system is the only system that can reproduce humeral head resectioning. Instruments can be inserted without the use of pins in the center of the glenoid during procedures.
 
“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 Zimmer Biomet president and CEO, Ivan Tornos. “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 (1) and efficiency.”
 
Surgical planning and patient-specific guide creation is possible with the Signature ONE Surgical Planning System 2.0 which the ROSA Shoulder System integrates with. Surgeons can access real-time intra-operative data in surgery to perform personalized plans for glenoid and humeral placement. 
 
“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,” John W. Sperling, Professor of Orthopedic Surgery at Mayo Clinic commented. “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.”
 
In addition to the ROSA Shoulder System, the ROSA Robotics portfolio includes the ROSA Knee System and ROSA Hip System. In the second half of 2024, the ROSA Shoulder will be commercially available in the US.