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Home » FDA clears enhanced version of Zimmer Biomet Rosa Knee surgical robot system

FDA clears enhanced version of Zimmer Biomet Rosa Knee surgical robot system

November 14, 2025 By Sean Whooley

Zimmer Biomet Rosa Knee OptimiZe surgical robot (1)
The Rosa Knee system with OptimiZe. [Image courtesy of Zimmer Biomet]
Zimmer Biomet (NYSE: ZBH) announced today that the FDA granted 510(k) clearance for its Rosa Knee surgical robot with OptimiZe technology.

The enhanced version of Rosa Knee offers a more customized experience for surgeons, the Warsaw, Indiana-based orthopedic giant says. It helps to deliver accurate and reproducible outcomes in robotic-assisted total knee replacement surgery. Zimmer Biomet submitted this to the FDA earlier this year alongside the expansion its surgical robotics suite with the acquisition of Monogram Technologies.

(Learn more about Rosa, Zimmer Biomet and the wide world of surgical robotics, see our special report on the space.)

Rosa Knee with OptimiZe personalizes the surgeon’s experience with customized intelligent surgical planning and new positioning, tracking and alignment features. The company said it helps to ensure accuracy and reduce user visibility. Zimmer Biomet — one of the largest orthopedic device companies in the world — says its offering provides a simplified user interface. It enables surgeons to choose the information they want to see, when they want to see it.

Dr. Peter Sculco, a hip and knee replacement. surgeon at Hospital for Special Surgery in New York, says the offering expands on Rosa’s existing benefits.

“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,” Sculco said. “The enhancement also provides more options to maintain an individualized surgical approach to optimize patient outcomes and surgeon confidence.”

Zimmer Biomet designed Rosa Knee with OptimiZe for use with the leading Persona Knee System. It enables surgeons who use functional alignment to use customizable surgeon profiles. These systematically provide surgical plans to automatically position the implant and balance the knee based on patient anatomy and surgeon preferences.

Rosa Knee with OptimiZe integrates with ZBEdge analytics as well. This enables surgeons to make data-driven intra-operative decisions, objectively assess their performance and understand the potential impact of clinical decisions on patient recovery.

(Shaun Braun, SVP and chief information and technology officer at Zimmer Biomet spoke with Medical Design & Outsourcing to discuss Rosa, OptimiZe, ZBEdge, and more earlier this year. Read about it here.)

The company said it offers the industry’s only automated kinematic alignment feature. This resurfaces the knee to restore its pre-arthritic position and native joint lines.

Other enhancements beyond planning and kinematic alignment include landmarking, with an easy-to-use painting feature to reduce variability. OptimiZe tracking enables collaborative resections with motion-sensitive Active Track. This eliminates the need for pinning the cut guide to. the bone, allowing bony resections to remain on-plane. The system’s simplified interface gives surgeons choices over workflows and display options to tailor the user experience for every case.

The company plans to roll out its new offering later this year in a targeted release. It expects commercial availability in the u.S. in the first quarter of 2026.

“As a leader in advancing innovation in orthopedic robotics, we are committed to improving and enhancing our robotic technologies to better meet the needs of surgeons and improve efficiency in the OR, with the ultimate goal of delivering better outcomes for patients,” said Braun. “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%.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Health Technology, Orthopedic Implants, Orthopedics, Regulatory/Compliance, Robotic-Assisted, Software / IT, Surgical, Surgical Robotics Tagged With: FDA, Zimmer Biomet

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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