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510(k) Data Aggregation

    K Number
    K190439
    Device Name
    Engage™ Partial Knee System
    Manufacturer
    Engage UNI, LLC
    Date Cleared
    2019-11-21

    (269 days)

    Product Code
    NJD, HSX
    Regulation Number
    888.3535
    Why did this record match?
    Applicant Name (Manufacturer) :

    Engage UNI, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis. - Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty - As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis. The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.
    Device Description
    The Engage™ Partial Knee System is a unicompartmental knee system comprised of tibial trays, tibial inserts, tibial anchors, and femoral components. The implant geometry is optimized for the medial compartment. The Engage™ Partial Knee System permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations. The tibial anchor are composed of Ti-6AI-4V alloy, the tibial insert is composed of UHMWPE, and the femoral component is composed of CoCrMo alloy. The tibial tray includes pegs and an engineered porous surface, while the femoral component includes pegs and a sintered porous coating; both of which are intended for biological fixation when used without bone cement and to enhance fixation when used with PMMA bone cement. The Engage™ Partial Knee System is intended for cemented or uncemented replacement of the medial compartment of the knee. The tibial anchors provide for supplemental fixation of the tibial tray when implanted without bone cement. The tibial anchor is not used when the tibial tray is implanted with bone cement.
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