510(k) K260796

Tahoe Unicondylar Knee System with TiNbN Overcoat by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics — Product Code HSX

K260796 is an FDA 510(k) premarket notification submitted by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics for the device "Tahoe Unicondylar Knee System with TiNbN Overcoat". The FDA issued a decision of Substantially Equivalent on April 2, 2026. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics has at least 1 other 510(k) clearance on record.