Balanced Knee System TriMax Porous Femoral Components

Balanced Knee System TriMax Porous Femoral Components is an FDA 510(k)-cleared medical device (K253161) manufactured by Ortho Development Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2025. Regulation: 8.