SkyWalker Total Knee System

SkyWalker Total Knee System is an FDA 510(k)-cleared medical device (K213873) manufactured by Microport Navibot International, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2022. Regulation: 8.