Clearance Summary
ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; received FDA 510(k) clearance under submission number K241000, sponsored by Depuy Ireland UC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-07-11.
- Submission: K241000
- Applicant / Sponsor: Depuy Ireland UC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2024-07-11
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.