Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in medical technology, has received U.S. FDA 510(k) clearance for ROSA® Knee with OptimiZe™—a next-generation enhancement of its ROSA® Knee System designed to deliver a more customized and precise surgical experience in robotic-assisted total knee replacement.
The new OptimiZe upgrades elevate the surgeon’s experience with intelligent, personalized planning and advanced positioning, tracking, and alignment capabilities aimed at improving accuracy and reducing user variability. The platform also features a streamlined, configurable interface that allows surgeons to selectively view information based on their workflow needs.
"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."
Engineered for compatibility with the industry-leading Persona® Knee System, ROSA Knee with OptimiZe enables surgeons who use functional alignment to leverage customizable profiles that automatically position implants and balance the knee based on each patient’s anatomy and the surgeon’s preferred parameters. For surgeons following kinematic alignment principles, the system offers the industry’s only automated kinematic alignment feature designed to restore the knee’s pre-arthritic mechanics and native joint lines.
"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 Shaun Braun, senior vice president and chief information and technology officer at Zimmer Biomet. "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%."1
Key Enhancements in ROSA Knee with OptimiZe™
· OptimiZe Planning™: Automates creation of personalized surgical plans guided by each surgeon’s knee balancing preferences.
· OptimiZe Landmarking™: A simplified painting-based landmarking tool that reduces variability.
· OptimiZe Tracking™: Active Track™ technology enables collaborative resections without pinning the Cut Guide, maintaining precision despite leg movement.
· OptimiZe Kinematic Alignment™: Automated planning based on bony landmarks to recreate pre-arthritic anatomy.
· OptimiZe Experience™: A clean, customizable user interface tailored to surgeon workflows and display preferences.
The system seamlessly integrates with ZBEdge® Analytics, offering data-driven intra-operative insights, performance assessment tools, and visibility into how surgical decisions may influence recovery.
Zimmer Biomet plans a targeted release of ROSA Knee with OptimiZe later this year, with full U.S. commercial availability expected in the first quarter of 2026.
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