www.fdanews.com/articles/190110-fda-clears-zimmer-biomets-robotic-knee-platform
FDA Clears Zimmer Biomet’s Robotic Knee Platform
February 5, 2019
The FDA granted Zimmer Biomet 510(k) clearance for its ROSA device, a robotically assisted platform for total knee replacement surgery.
The electromechanical arm comes with 3D pre-operative planning tools and real-time data on soft tissue and bone anatomy that helps to improve the accuracy of bone cuts.
The device, which is intended for operating room use, also uses a proprietary imaging protocol to generate preoperative images.