Clearance Summary
Tahoe Unicondylar Knee System with TiNbN Overcoat received FDA 510(k) clearance under submission number K260796, sponsored by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-04-02.
- Submission: K260796
- Applicant / Sponsor: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3520
- Decision date: 2026-04-02
Classification & Regulation
This clearance is catalogued under FDA product code HSX and 21 CFR 888.3520, within the Orthopedic review panel as a Class II device.