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

Zimmer Biomet received U.S. FDA 510(k) clearance for an enhanced version of its ROSA Knee System, known as ROSA Knee with OptimiZe12578.

The OptimiZe upgrade focuses on providing a more customized surgical experience and includes features like intelligent planning, improved positioning, tracking, and precise alignment135.

This version integrates OptimiZe Planning™, a proprietary algorithm that enables surgeons to create personalized surgical profiles, reportedly reducing planning time by an average of 46%1.

ROSA Knee with OptimiZe is designed for use with the Persona knee system, further supporting tailored knee replacement procedures1.

The enhanced ROSA Knee system was designed in collaboration with experienced ROSA surgeons to improve the personalization, accuracy, and efficiency of robotic-assisted knee replacement15.

Zimmer Biomet announced the FDA clearance in mid-November 2025157.

Sources:

1. https://www.beckersspine.com/orthopedic/zimmer-biomets-enhanced-version-of-rosa-earns-fda-clearance/

2. https://www.massdevice.com/fda-clears-enhanced-rosa-knee-zimmer-biomet/

3. https://www.orthoworld.com/zimmer-biomet-earns-510k-clearance-for-enhanced-rosa-knee/

5. https://www.surgicalroboticstechnology.com/news/zimmer-biomet-receives-fda-clearance-for-enhanced-version-of-rosa-knee-robotic-technology/

7. https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/rosa--knee-system.html

8. https://www.investing.com/news/company-news/zimmer-biomet-receives-fda-clearance-for-enhanced-knee-surgery-robot-93CH-4358737