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510(k) Data Aggregation

    K Number
    K051407
    Device Name
    LEGEND ALL-POLY CUP
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Date Cleared
    2005-09-08

    (100 days)

    Product Code
    JDI,LPH
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for cemented use only in hip arthroplasty applications whose indications include:

    • Osteoarthritis, Rheumatoid arthritis, or other Osteoarthrosis 1.
      1. Certain femoral neck fractures or dislocation
      1. Post traumatic arthritis
    • Idiopathic avascular necrosis of the femoral head 4.
    • Benign or malignant bone tumors where sufficient bone stock exists to seat the 5. prosthesis
    • Previously failed surgery 6.
    Device Description

    Legend™ All-poly Cup

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies related to the Legend™ All-poly Cup. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on how the device's performance was evaluated against specific acceptance criteria.

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