K222632 is an FDA 510(k) clearance for the UHR Bipolar Implants, Restoration GAP II Implants. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 21, 2022, 51 days after receiving the submission on August 31, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K222632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2022 |
| Decision Date | October 21, 2022 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |