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    K Number
    K253713

    Validate with FDA (Live)

    Device Name
    Arthrex Variable Angle (VA) Proximal Tibia Plating System
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-01-21

    (58 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K220937,K242554,K213837,K203294,K150456,K143614,K123241,K111253,K103705,K241592,K210837,K222244
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K242554, K203294, K150456, K143614, K123241, K111253, K103705, K150456, K143614, K111253, K103705, K241592

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex Lateral Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.

    The Arthrex Medial Proximal Tibia Plate is indicated for adult patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures of the tibia.

    The Arthrex Posteromedial Proximal Tibia Plates are intended to be used for internal bone fixation for bone fractures in the tibia.

    Device Description

    The Arthrex Variable Angle (VA) Proximal Tibia Plating System is designed for repairing fractures of the tibia. The Arthrex Variable Angle (VA) Proximal Tibia Plating System consists of two Lateral Proximal Tibia Plate types (Standard and High), Posteromedial Proximal Tibia Plates, and Medial Proximal Tibia Plates. The Lateral Proximal Tibia Plates are anatomically contoured, available in left and right configurations, varying plate lengths of 78 mm to 239 mm. The primary difference between the Standard and High Lateral Proximal Tibia Plates is that the High Lateral Proximal Tibia Plate includes four additional 2.7 mm screw holes proximally. The Medial Proximal Tibia Plates are anatomically contoured, available in left and right configuration, and varying plate lengths of 94 mm to 202 mm. The Posteromedial Proximal Tibia Plates are anatomically contoured straight plates offered in varying plate lengths of 87 mm to 137 mm. The Lateral, Posteromedial, and Medial Proximal Tibia Plates within the Arthrex Variable Angle (VA) Proximal Tibia Plating System accept variable angle (VA) and nominal angle locking screws, KreuLock™ screws, cortical screws, as well as cancellous screws. Additionally, the Variable Angle (VA) Proximal Tibia Plates includes K-wire holes for temporary fixation and suture holes to assist in soft tissue management. The proposed plates are manufactured from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136 (ISO 5832-3). The Variable Angle (VA) Proximal Tibia Plates are single use and sold either sterile (Gamma) or non-sterile.

    The Arthrex Variable Angle (VA) Proximal Tibia Plating System are compatible with the following Arthrex Screws:

    • 2.7 mm Cortical Screw and 2.7 mm VAL Screw (K220937)
    • 2.7 mm VAL KreuLock Screws (K242554)
    • 3.0 mm Low Profile VA Locking Screw (K213837)
    • 3.0 mm KreuLock™ Compression Screw, 3.0 Low Profile VA Locking Screw, Hybrid, 3.0 mm Hybrid KreuLock™ Compression Screw (K242554)
    • 3.5 mm Low Profile Screw (K203294, K150456, K143614, K123241, K111253, K103705)
    • 3.5 mm Low Profile Locking Screws (K150456, K143614, K111253, K103705)
    • 3.5 mm Variable Angle Locking (VAL) Screw, Reinforced, 3.5 mm Variable Angle Locking (VAL) KreuLock™ Screw, Reinforced, 3.5 VAL Screw, 3.5 mm VAL KreuLock Screws (K241592)
    • 4.0 mm Low Profile Screw, Cancellous (K150456, K143614, K111253, K103705)
    AI/ML Overview

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