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510(k) Data Aggregation

    K Number
    K252959

    Validate with FDA (Live)

    Device Name
    WRISTAR MultiAx Distal Radius Kit
    Manufacturer
    Intrauma S.p.A
    Date Cleared
    2025-11-12

    (57 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K071184,K083694
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wristar MultiAx Distal Radius Kit is indicated for:

    • Fixation of complex intra- and extra-articular fractures of the distal radius
    • osteotomies of the distal radius
    Device Description

    The WRISTAR MultiAx Distal Radius Sterile Kit is indicated for both intra-articular and extra-articular fractures of the distal radius (2R3-A2 and 2R3-A3, 2R3-B/C) and for distal radius osteotomies. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via MultiAxial and cortical screws.

    The WRISTAR MultiAx Distal Radius Volar Plate is available in various lengths to accommodate patient anatomy and fracture type of the malleolus bone. The plate is provided either with threaded holes or tapered holes. The head of the plate has a shape and contour that provides bone support and a low profile that minimizes the potential for soft tissue irritation.

    Screws are available in two designs: cortical and MultiAx.

    AI/ML Overview

    N/A

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