K213701 is an FDA 510(k) clearance for the Exeter® X3® RimFit® Cup. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on February 1, 2022, 69 days after receiving the submission on November 24, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K213701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2021 |
| Decision Date | February 01, 2022 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |