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510(k) Data Aggregation

    K Number
    K200765
    Device Name
    Genius / Genuin Total Knee System
    Date Cleared
    2021-05-05

    (407 days)

    Product Code
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biorad Medisys PVT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated for use only with bone cement for patients suffering from: Severe knee joint pain, loss of mobility and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, Correction of functional deformities. Posttraumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, Varus or flexion trauma. Knee fractures untreatable by other methods.
    Device Description
    The Genius / Genuin Total Knee System has 3 major components: - Femoral component - Tibial component - Includes Tibial Tray and Tibial Insert - Patellar component
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