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510(k) Data Aggregation

    K Number
    K260069

    Validate with FDA (Live)

    Device Name
    DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
    Manufacturer
    Synthes GmbH
    Date Cleared
    2026-03-09

    (59 days)

    Product Code
    HRS,HTD,HWC,HWT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    12 - 21
    Reference & Predicate Devices
    K233665,K011978,K050646,K082624
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System is indicated for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) where growth plates have fused.

    VOLT Proximal Tibia Plates:
    Indicated for fractures of the proximal end segment of the tibia.

    VOLT Proximal Tibia Plates, Long:
    Indicated for fractures of the proximal end segment of the tibia with or without extension into the diaphysis.

    Device Description

    The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System comprises implantable devices intended for the stabilization and internal fixation of proximal tibia fractures. The system offers five families of stainless steel 3.5-mm contoured plates with variable angle screw holes. Plates within the VOLT™ Proximal Tibia 3.5 Plating System are available in various lengths, sterile or non-sterile, and are single-use only. The system also includes non-implantable, dedicated guide blocks, sizing templates, and trays as accessories for use with the implants.

    AI/ML Overview

    N/A

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