Balanced Knee Revision System Trabecular Tibial Cone Augments

Balanced Knee Revision System Trabecular Tibial Cone Augments is an FDA 510(k)-cleared medical device (K182085) manufactured by Ortho Development Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 2018. Regulation: 8.