K240639 is an FDA 510(k) clearance for the PINNACLETM Constrained Acetabular Liners. This device is classified as a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II - Special Controls, product code KWZ).
Submitted by Depuy Ireland UC (Cork, GB). The FDA issued a Cleared decision on April 4, 2024, 29 days after receiving the submission on March 6, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3310.
| 510(k) Number | K240639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2024 |
| Decision Date | April 04, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3310 |