DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System— 510(k) K254093

Name: FDA 510(k) clearance K254093
Creator: U.S. Food and Drug Administration
Published: 2026-03-10

Substantially Equivalent

Synthes GmbH

FDA 510(k) clearance K254093 for DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System, Substantially Equivalent on 2026-03-10. Applicant: Synthes GmbH.

Summary

Synthes GmbH's DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System is filed under HRS, bone fixation plates. The record doesn't list plate lengths or components.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Synthes filed from Zuchwil, Switzerland. The decision came 81 calendar days after receipt (December 19, 2025 to March 10, 2026).

Clearance details

Applicant: Synthes GmbH
Advisory panel: Unknown
Date received: 2025-12-19
Decision date: 2026-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuchwil, CH

Download summary PDF View on FDA.gov ↗

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K243715 — Synthes Patient Specific Implants2025-11-12
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K233994 — VOLT Proximal Humerus 3.5 Plating System2024-07-26

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