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FDA 510(k)

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

K-Number: K254093 · 2026-03-10

ApplicantSynthes GmbH
Decision Date2026-03-10
Product Code
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes GmbH. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K254093. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Synthes GmbH. The 510(k) number is K254093.

When did DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System receive FDA 510(k) clearance?

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System received FDA 510(k) clearance on 2026-03-10, under 510(k) number K254093.

Who is the listed applicant for DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System?

The FDA 510(k) record lists Synthes GmbH as the applicant. This does not by itself establish the device manufacturer.

Other records listing Synthes GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemK254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemK243715Synthes Patient Specific ImplantsK241927Synthes Graphic Case & Tray SystemK233994VOLT™ Proximal Humerus 3.5 Plating SystemK233967DePuy Synthes MatrixSTERNUM Fixation System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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