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510(k) Data Aggregation

    K Number
    K260353

    Validate with FDA (Live)

    Device Name
    Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-03

    (28 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K241592,K203294,K150456,K143614,K103705,K141735,K243995,K180310
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Humeral Plating System is indicated for fractures and fracture-dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

    The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

    Device Description

    The Arthrex Humeral Plating (Anatomic Humeral Plate) and Cerclage Button consist of contoured humeral plates and a 4.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 92 - 265 mm and include suture holes for soft tissue repair. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294), Arthrex 4.0 mm screws (K150456, K143614, and K103705), and Arthrex 4.5 mm screws (K141735).

    AI/ML Overview

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