Zimmer Biomet announces FDA clearance of ROSA Knee with OptimiZe

Zimmer Biomet (ZBH) Holdings announced FDA clearance of 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 outcomes in robotic-assisted total knee replacement surgery. 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 industry leading Persona Knee System4, 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 own anatomy and the surgeon’s preferences. For surgeons who prefer kinematic alignment, the system offers the industry’s only automated kinematic alignment feature to resurface the knee with the goal of restoring its pre-arthritic position and native joint lines. Zimmer Biomet will conduct a targeted release of ROSA Knee with OptimiZe later this year with commercial availability in the U.S. expected in the Q1 of FY26.