K051995 is an FDA 510(k) clearance for the PROFEMUR RENAISSANCE HIP STEM. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III - Premarket Approval, product code JDL).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 22, 2005, 28 days after receiving the submission on July 25, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.
| 510(k) Number | K051995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2005 |
| Decision Date | August 22, 2005 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3320 |