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    K Number
    K060412
    Device Name
    ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
    Manufacturer
    AUSTRALIAN SURGICAL DESIGN & MANUFACTURE
    Date Cleared
    2006-05-17

    (90 days)

    Product Code
    HRY
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    **AUSTRALIAN SURGICAL DESIGN **& MANUFACTURE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee where the other condyle remains intact. It is intended to be used only with bone cement in patients suffering from the following conditions: - . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease excluding rheumatoid arthritis . - Correction of functional deformity such as varus or valgus deformities. .
    Device Description
    The Active Unicompartmental Knee System is a modular re-surfacing unicompartmental knee implant system, consisting of a metallic femoral component and a UHMWPE partial tibial component.
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