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.

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 ↗

More clearances from Synthes GmbH

view all

K260069 — DePuy Synthes VOLT Proximal Tibia 3.5 Plating System2026-03-09
K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System2026-03-02
K243715 — Synthes Patient Specific Implants2025-11-12
K241927 — Synthes Graphic Case & Tray System2025-03-28
K233994 — VOLT Proximal Humerus 3.5 Plating System2024-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.