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510(k) Data Aggregation

    K Number
    K172872
    Device Name
    DePuy Synthes Femoral Neck System
    Manufacturer
    DePuy Synthes
    Date Cleared
    2018-03-05

    (165 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K953607,K161616,K791619,K062066
    Predicate For
    K182154
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Femoral Neck System (FNS) is indicated for basilar femoral neck fractures in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.

    Device Description

    The subject Femoral Neck System is comprised of implants designed to treat basilar femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral head. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study related to an AI/ML medical device. The document is an FDA 510(k) clearance letter for the DePuy Synthes Femoral Neck System, a metallic bone fixation appliance.

    Therefore, I cannot provide a response to the prompt's request for acceptance criteria and study details for an AI/ML device.

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