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Medical Devices / Submissions and Approvals

FDA Clears Zimmer Biomet’s Robotic Knee Platform

Feb. 6, 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.

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