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510(k) Data Aggregation

    K Number
    K992490
    Device Name
    B2C HIP SYSTEM
    Manufacturer
    Date Cleared
    1999-08-19

    (24 days)

    Product Code
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEPINE GROUPE SPA.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity. The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup. The indications for use of the B2C hip system are as follows: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies. Salvage of previous unsuccessful procedures such as osteosynthesis, joint reconstruction, arthrodesis, hemi or total hip arthroplasty. Bipolar head or Austin Moore type head revision. Fracture or avascular necrosis of the femoral head in the elderly. Replacement of acetabular and stem component in total hip arthroplasty. Primary arthroplasty of the acetabular in dysplastic hips.
    Device Description
    Not Found
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