K233980 is an FDA 510(k) clearance for the ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on March 21, 2024, 94 days after receiving the submission on December 18, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K233980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2023 |
| Decision Date | March 21, 2024 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |