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510(k) Data Aggregation

    K Number
    K032385
    Device Name
    GLOBAL PRESS-FIT STEM
    Manufacturer
    Date Cleared
    2003-10-30

    (87 days)

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

    GLOBAL MEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Global Press-fit Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because of: degenerative joint disease, including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.
    Device Description
    The Global Press-fit stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is available is sizes ranging from 9mm to 17mm. The body tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a tri-planar wedge geometry that is conducive to axial and rotational stability. The distal stem is conical in shape with sharp splines to enhance rotational stability. Stems larger than 11mm have a coronal slot in the distal third to aid in the reduction of thigh pain. A Morse type taper is used to attach modular femoral heads. The stem is available with neutral, and right and left anteverted necks. No calcar collar is present on this stem. The proximal lateral shoulder of the stem has a threaded hole for insertion and extraction tools. The proximal body of the stem has a circumferential porous coating of sintered CP titanium beads (ASTM F67). The femoral heads utilized with the Global Press-fit Hip are machined from wrought CoCrMo alloy (ASTM F799). They are available in 22mm, 28mm diameters. The 22mm heads have two neck lengths, while the 28mm and 32mm heads have five neck lengths.
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