K193549 is an FDA 510(k) clearance for the SIGMA High Performance (HP) Partial Knee System. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HRY).
Submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on April 16, 2020, 118 days after receiving the submission on December 20, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K193549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2019 |
| Decision Date | April 16, 2020 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3530 |