Clearance Summary
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP received FDA 510(k) clearance under submission number K213781, sponsored by Depuy Ireland UC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-01-18.
- Submission: K213781
- Applicant / Sponsor: Depuy Ireland UC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3565
- Decision date: 2022-01-18
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.