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FDA 510(k)

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System

K-Number: K254054 · 2026-03-02

ApplicantSynthes GmbH
Decision Date2026-03-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 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 2026-03-02 under 510(k) number K254054. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System?

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Synthes GmbH. The 510(k) number is K254054.

When did VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System receive FDA 510(k) clearance?

VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System received FDA 510(k) clearance on 2026-03-02, under 510(k) number K254054.

Who is the listed applicant for VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System?

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

What is the FDA product code for VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System?

The FDA product code for VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System is HRS.

Related Clinical Trials

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NCT07511478Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle FracturesCOMPLETED

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.

K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemK260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemK243715Synthes Patient Specific ImplantsK241927Synthes Graphic Case & Tray SystemK233994VOLT™ Proximal Humerus 3.5 Plating SystemK233967DePuy Synthes MatrixSTERNUM Fixation System

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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