Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology

WARSAW, Ind., Nov. 14, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) 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 outcomes1 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 accuracy1 and reduce user variability.2 The technology provides a simplified user interface that allows surgeons to choose the information they want to see, when they want to see it.

“More and more surgeons are integrating robotic technologies, because they empower surgeons to achieve better outcomes for patients3,” said Dr. Peter Sculco, hip and knee replacement surgeon at Hospital for Special Surgery in New York. “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.2 The enhancement also provides more options to maintain an individualized surgical approach to optimize patient outcomes and surgeon confidence.”

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