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

Core Insights - Zimmer Biomet Holdings, Inc. has received FDA 510(k) clearance for ROSA Knee with OptimiZe, an advanced version of its ROSA Knee System aimed at enhancing personalized surgical planning and improving outcomes in robotic-assisted total knee replacement surgery [1][2]. Product Features - ROSA Knee with OptimiZe offers customized intelligent surgical planning, new positioning, tracking, and alignment features to enhance accuracy and reduce variability among users [3]. - The system includes five key enhancements: - OptimiZe Planning for customized surgical plans based on individual preferences - OptimiZe Landmarking to minimize user variability in landmarking - OptimiZe Tracking for motion-sensitive resections without the need for pinning - OptimiZe Kinematic Alignment for automated resurfacing to restore pre-arthritic positions - OptimiZe Experience with a simplified user interface for tailored workflows [5]. Surgeon Feedback - Surgeons are increasingly adopting robotic technologies for better patient outcomes, and ROSA Knee with OptimiZe provides tools to reduce variability and optimize implant placement [4]. - The system is designed to work with the Persona Knee System, allowing for customizable profiles that align with both patient anatomy and surgeon preferences [4]. Integration and Future Plans - ROSA Knee with OptimiZe integrates with ZBEdge® Analytics, enabling data-driven intra-operative decisions and performance assessments [6]. - A targeted release of the product is planned for later this year, with commercial availability expected in the U.S. in the first quarter of 2026 [6].