Arthrex iBalance Partial Knee System

Arthrex iBalance Partial Knee System is an FDA 510(k)-cleared medical device (K251453) 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 June 30, 2025. Regulation: 8.