Zimmer Biomet Updates Rosa Knee Robot with FDA Clearance

Zimmer Biomet has received FDA 510(k) clearance for an updated version of its Rosa knee surgery robot, named Rosa 1.5 internally. The clearance covers Rosa Knee with Optimize, featuring a simplified user interface and streamlined surgical workflow, designed to accelerate procedures and improve efficiency.

The updated system enhances kinematic alignment procedures, restoring natural knee movement, and supports customized surgical plans based on individual knee balancing preferences. The faster registration process allows surgeons to perform procedures more efficiently, while display and workflow options can be tailored for each case.

Zimmer expects the updated robot to drive accelerated Rosa installs and become a “meaningful contributor” to sales in 2026. The device is part of a broader growth strategy, including iodine-treated implants and products from the Paragon 28 acquisition. Additionally, Zimmer’s $177 million Monogram Technologies takeover will expand its knee offering in 2027, integrating semi-autonomous robotics with its implant portfolio.

25-11-2025