The ROSA Shoulder system is designed to provide surgeons with the flexibility to perform a total shoulder replacement using anatomic or reverse techniques and to enable precise placement of the implant to achieve improved outcomes
The ROSA Shoulder system helps surgeons during total shoulder replacement. (Credit: Piron Guillaume on Unsplash)
US-based medical technology company Zimmer Biomet has secured the US Food and Drug Administration (FDA) 510(k) approval for its ROSA Shoulder System for robotic-assisted shoulder replacement surgery.
The ROSA Shoulder system is designed to provide surgeons with the flexibility to perform a total shoulder replacement using anatomic or reverse techniques and to enable precise placement of the implant to improve outcomes.
It is one of the only systems that can reproduce humeral head resectioning and enable the insertion of instruments into incisions, without needing a pin in the glenoid during procedures.
According to the company, ROSA Shoulder is the world’s first robotic surgery system for shoulder replacement and the fourth application for its ROSA Robotics portfolio.
The portfolio also includes the ROSA Knee System for total knee arthroplasty and the ROSA Hip System for total hip replacement.
Zimmer Biomet president and CEO Ivan Tornos 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 accuracy1 and efficiency.”
Zimmer Biomet said that like all other ROSA Robotics applications, ROSA Shoulder will support data-informed physician decision-making based on a patient’s unique anatomy.
The system will strengthen its advanced shoulder implant portfolio and joins ZBEdge Dynamic Intelligence, which can enhance its digital technologies, robotics, and implant solutions.
The ROSA Shoulder can be integrated with the company’s newly released Signature ONE Surgical Planning System 2.0, which uses a 3-D image-based approach.
The system will provide real-time, intra-operative data during the surgery, to help surgeons control, execute and validate personalised plans for glenoid and humeral placement.
Zimmer Biomet intends to commercialise the ROSA Shoulder in the US in the second half of this year.
Furthermore, the medical technology company will work with the mymobility Digital Care Management Platform to strengthen the ZBEdge Dynamic Intelligence portfolio.
Mayo Clinic professor of orthopaedic surgery John W Sperling 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.”