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510(k) Data Aggregation

    K Number
    K053557
    Device Name
    ESKA-LIBUR HIP STEM
    Date Cleared
    2006-01-20

    (30 days)

    Product Code
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESKA IMPLANTS GMBH & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ESKA-LIBUR Hip Stem is indicated for use in the treatment rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, vascular necrosis, non-union of femoral neck fractures, fracture dislocation of the hip, conversion of unsuccessful arthodeses and revision of previous hip surgeries.
    Device Description
    The ESRA LILOR The stem is available in thirteen sizes with a distal M/L dimension ranging alle 150 5645-4. The Stein 120mm to 180mm. It is modular in nature such that a from 7mm to 19.5mm, and lengals xosal body accepts an adaptor that has male tapers on both ends. One end engages the hip stem and the other a modular head. The distal end of the stem is color buffed while proximal body has the same Spongiosa Metal II® Surface cast into same as the predicate ESKA Modular Hip Stem.
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    K Number
    K030867
    Device Name
    ESKA MODULAR HIP SYSTEM CEMENTED
    Manufacturer
    Date Cleared
    2003-09-22

    (187 days)

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

    ESKA IMPLANTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ESKA Modular Hip System Cemented is indicated for cemented use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.
    Device Description
    The ESKA Modular Hip System Cemented is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The modular femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. They are available in varying primary and revision lengths. There are collared and collarless options. Standard and lateralized geometries are offered. The stems feature a grit-blasted surface along their entire length and a 12/14 Morse type taper trunnion. The modular femoral heads are available in various diameters from 26mm to 32mm, and in varying neck lengths. The acetabular components are hemispherical all-polyethylene designs in a range of inner and outer diameters, with various offset options. The outer diameters incorporate radial and circumferential cement retention grooves and a titanium radiographic marker wire. Materials: The devices are manufactured from CoCrMo alloy and Ultra High Molecular Weight Polyethylene ( UHMWPE ) per ASTM and ISO standards. Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.
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