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510(k) Data Aggregation

    K Number
    K040383
    Device Name
    TRIFLANGE II ACETABULAR CUP SYSTEM
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    2004-05-12

    (85 days)

    Product Code
    LPH,MEH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K001277,K001534
    Predicate For
    K201348,K232556
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TriFlange II Acetabular Cup System is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

    Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

    Total hip replacement is indicated in the following conditions:

    • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
    • Avascular necrosis of the femoral head.
    • Acute traumatic fracture of the femoral head or neck.
    • Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
    • Certain cases of ankylosis.
    Device Description

    The patient specific TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup with three patient specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges.

    AI/ML Overview

    The provided text is a 510(k) summary for the TriFlange II Acetabular Cup System, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study with acceptance criteria for device performance as would be expected for a novel AI/software device.

    Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided document. The 510(k) summary focuses on device description, intended use, indications for use, and a comparison to predicate devices to establish substantial equivalence.

    The document does not contain the information required to answer your specific questions.

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