Arthrex iBalance TKA System

Arthrex iBalance TKA System is an FDA 510(k)-cleared medical device (K152252) manufactured by Arthrex, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 2015. Regulation: 8.