K213781 is an FDA 510(k) clearance for the ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on January 18, 2022, 46 days after receiving the submission on December 3, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K213781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2021 |
| Decision Date | January 18, 2022 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |