Clearance Summary
Consensus Knee System with TiNbN received FDA 510(k) clearance under submission number K241180, sponsored by Shalby Advanced Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-01-14.
- Submission: K241180
- Applicant / Sponsor: Shalby Advanced Technologies
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2025-01-14
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.