Zimmer Biomet Earns 510(k) Clearance for Enhanced ROSA Knee

Zimmer Biomet announced FDA 510(k) clearance to market ROSA Knee with OptimiZe, an enhanced version of its ROSA Knee System that offers a more customized experience for surgeons to help deliver accurate and reproducible outcomes1 in robotic-assisted total knee replacement.

Targeted release of ROSA Knee with OptimiZe will commence by year-end, with commercial U.S. availability slated for 1Q26.

ROSA Knee with OptimiZe personalizes the surgeon’s experience with customized intelligent surgical planning and new positioning, tracking and alignment features to help ensure accuracy and reduce user variability. The technology provides a simplified user interface that allows surgeons to choose the information they want to see, when they want to see it.

Designed for use with the Persona Knee System, ROSA Knee with OptimiZe enables surgeons who use functional alignment to use customizable surgeon profiles that systematically provide surgical plans to automatically position the implant and balance the knee based on the patient’s anatomy and surgeon’s preferences. For surgeons who prefer kinematic alignment, the system offers automated kinematic alignment to resurface the knee with the goal of restoring its pre-arthritic position and native joint lines.

ROSA Knee with OptimiZe features:

• OptimiZe Planning: Creates a customized surgical plan to guide implant positioning based on surgeon individual knee balancing preferences.
• OptimiZe Landmarking: Easy-to-use painting feature reduces user landmarking variability.
• OptimiZe Tracking: Collaborative resections with motion-sensitive Active Track™ eliminate the need for pinning the Cut Guide to the bone and allows bony resections to remain on plane even with leg movement.
• OptimiZe Kinematic Alignment: Automated kinematic alignment plan based on bony landmarks, to resurface the knee to its pre-arthritic position.
• OptimiZe Experience: Simplified user interface allows the surgeon to choose specific workflow and display options to tailor user experience for every case.

ROSA Knee with OptimiZe integrates with ZBEdge Analytics to support data-driven intra-operative decisions, objectively assess performance and understand the potential impact of clinical decisions on patient recovery.

Shaun Braun, Senior Vice President and Chief Information and Technology Officer at Zimmer Biomet, said, “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. With our proprietary algorithm, OptimiZe Planning, surgeons can create customized profiles that generate personalized surgical plans, which can reduce planning time by an average of 46%.”

Source: Zimmer Biomet