Zimmer Biomet Secures FDA Clearance for Upgraded ROSA Knee Robotic System
Zimmer Biomet has obtained FDA clearance for ROSA Knee with OptimiZe, an upgraded version of its robotic-assisted knee replacement platform. The enhanced system introduces new planning, tracking, and alignment features intended to support surgeons in achieving accurate and repeatable results during total knee arthroplasty.
The updated system provides surgeons with a more tailored workflow through customizable planning tools and a simplified interface that allows them to prioritize the information they want to view during a procedure. Dr. Peter Sculco, a hip and knee replacement surgeon at the Hospital for Special Surgery in New York, said the enhancement builds on the original system’s strengths. “ROSA Knee with OptimiZe expands on existing benefits of ROSA Knee by giving surgeons new tools to reduce landmark variability to optimize implant placement and reproducibility,” he said, noting that these options help maintain an individualized surgical approach.
Designed for use with the Persona Knee System, ROSA Knee with OptimiZe supports both functional and kinematic alignment techniques. Surgeons using functional alignment can rely on customizable profiles that automate implant positioning based on patient anatomy and surgeon preference. Those who prefer kinematic alignment can access an automated feature aimed at restoring the knee’s pre-arthritic orientation and native joint lines.
Zimmer Biomet developed the upgraded system in collaboration with its network of ROSA surgeons. Shaun Braun, the company’s senior vice president and chief information and technology officer, said the focus was on personalization and efficiency. “ROSA Knee with OptimiZe was designed in partnership with our seasoned team of ROSA surgeons to make robotic-assisted knee replacement surgery more personalized, accurate and efficient for surgeons,” he said. The company noted that its OptimiZe Planning algorithm may reduce planning time significantly.
The technology integrates with ZBEdge Analytics, allowing surgeons to review intraoperative data, assess performance, and understand how surgical decisions may influence patient recovery. Zimmer Biomet plans a limited release later this year, with full U.S. commercial availability expected in early 2026.
