Stabil Orthopaedic Solutions Total Knee System

Stabil Orthopaedic Solutions Total Knee System is an FDA 510(k)-cleared medical device (K183225) manufactured by Stabil Orthopaedic Solutions, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 14, 2019. Regulation: 8.