K252824 is an FDA 510(k) clearance for the Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head..
Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on March 12, 2026, 188 days after receiving the submission on September 5, 2025.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K252824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | — |
| Device Class | — |