Clearance Summary
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology received FDA 510(k) clearance under submission number K240678, 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 2024-06-18.
- Submission: K240678
- Applicant / Sponsor: Depuy Ireland UC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3565
- Decision date: 2024-06-18
Classification & Regulation
This clearance is catalogued under FDA product code MBH and 21 CFR 888.3565, within the Orthopedic review panel as a Class II device.