Zimmer Biomet Holdings announced on November 14, 2025, that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for ROSA Knee with OptimiZe, an enhanced version of its robotic-assisted knee replacement surgery system. The upgraded technology offers personalized surgical planning and new positioning, tracking, and alignment features designed to improve accuracy and reduce user variability in total knee replacement procedures.
Enhanced Surgical Planning Capabilities
The ROSA Knee with OptimiZe system introduces intelligent surgical planning through its proprietary OptimiZe Planning algorithm. According to Zimmer Biomet's data, surgeons can create customized profiles that generate personalized surgical plans, reducing planning time by an average of 46%. The system allows surgeons to maintain individualized surgical approaches while providing systematic guidance for implant positioning and knee balancing based on patient anatomy and surgeon preferences.
"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," said Shaun Braun, senior vice president and chief information and technology officer at Zimmer Biomet.
Five Key System Enhancements
The enhanced ROSA Knee system features five primary improvements over the original version:
OptimiZe Planning creates customized surgical plans to guide implant positioning based on individual surgeon knee balancing preferences.
OptimiZe Landmarking incorporates an easy-to-use painting feature that reduces user landmarking variability.
OptimiZe Tracking enables collaborative resections with motion-sensitive Active Track technology, eliminating the need for pinning the Cut Guide to bone and allowing bony resections to remain on plane even with leg movement.
OptimiZe Kinematic Alignment provides automated kinematic alignment planning based on bony landmarks to resurface the knee to its pre-arthritic position.
OptimiZe Experience offers a simplified user interface allowing surgeons to choose specific workflow and display options tailored to each case.
Clinical Applications and Integration
The system is designed for use with Zimmer Biomet's industry-leading Persona Knee System. For surgeons utilizing functional alignment techniques, the technology provides customizable surgeon profiles that systematically deliver surgical plans to automatically position implants and balance knees. For those preferring kinematic alignment, the system offers what the company describes as the industry's only automated kinematic alignment feature.
Dr. Peter Sculco, a hip and knee replacement surgeon at Hospital for Special Surgery in New York, noted that "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."
Market Availability and Data Integration
ROSA Knee with OptimiZe integrates with ZBEdge Analytics to enable surgeons to make data-driven intra-operative decisions, objectively assess performance, and understand the potential impact of clinical decisions on patient recovery.
Zimmer Biomet plans to conduct a targeted release of the enhanced system later in 2025, with commercial availability in the United States expected in the first quarter of 2026. The company positions this advancement as part of its broader commitment to improving robotic technologies to better meet surgeon needs and enhance operating room efficiency.
