K202194 is an FDA 510(k) clearance for the ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology. 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 (Cork, IE). The FDA issued a Cleared decision on November 25, 2020, 112 days after receiving the submission on August 5, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K202194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2020 |
| Decision Date | November 25, 2020 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| 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 |