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    K Number
    K254093

    Validate with FDA (Live)

    Device Name
    DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
    Manufacturer
    Synthes GmbH
    Date Cleared
    2026-03-10

    (81 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    12 - 120
    Reference & Predicate Devices
    K233665,K082807
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VOLT™ Medial Distal Femur 3.5 Plating System is indicated for internal fixation of isolated medial condylar fractures as a standalone fixation device. For all other distal femur fractures, corrective osteotomies, non-unions, or malunions, it is indicated for use as an adjunct to primary fixation.

    The VOLT™ Medial Distal Femur 3.5 Plating System is intended for adults and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

    Device Description

    The DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is a family of implantable devices consisting of 3.5mm anatomic Medial Distal Femur plates with variable angle screw holes. These plates are available in Stainless Steel, supplied sterile, and intended for single use only. These plates accept VOLT™ Stainless Steel screws, including VOLT™ 3.5 mm locking, 3.5 mm cortical, and 4.0 mm cancellous screws.

    AI/ML Overview

    N/A

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