K254093 is an FDA 510(k) clearance for the DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System..
Submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on March 10, 2026, 81 days after receiving the submission on December 19, 2025.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K254093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2025 |
| Decision Date | March 10, 2026 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | — |
| Device Class | — |