Tahoe Unicondylar Knee System with TiNbN Overcoat

Tahoe Unicondylar Knee System with TiNbN Overcoat is an FDA 510(k)-cleared medical device (K260796) manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2026. Regulation: 8.