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510(k) Data Aggregation

    K Number
    K972931
    Device Name
    PLUS EPF ACETABULAR CUP
    Manufacturer
    HHL CONSULTING
    Date Cleared
    1997-11-13

    (97 days)

    Product Code
    LWJ
    Regulation Number
    888.3360
    Why did this record match?
    Applicant Name (Manufacturer) :

    HHL CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PLUS EPF Acetabular Cup is intended for all types of arthrosis. such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
    Device Description
    The PLUS EPF Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.
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