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510(k) Data Aggregation

    K Number
    DEN220033
    Device Name
    MISHA Knee System
    Manufacturer
    Date Cleared
    2023-04-10

    (308 days)

    Product Code
    Regulation Number
    888.3610
    Why did this record match?
    Product Code :

    QVV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MISHATM Knee System is indicated for patients with medial compartment knee osteoarthritis that have failed to find relief in surgical and/or non-surgical treatment modalities and are still experiencing pain that interferes with activities of daily living and are also unwilling to undergo or ineligible for total knee replacement due to age or absence of advanced osteoarthritis.
    Device Description
    The MISHATM Knee System (Figure 1) is a prescription use, extra-capsular knee implant device that is comprised of a tibial base subassembly, femoral base subassembly, absorber subassembly, piston subassembly and locking screws. The tibial base subassembly, femoral base subassembly, piston subassembly and absorber subassembly are provided pre-assembled, and the implant is fixed with locking screws to the medial cortices of the distal femur and proximal tibia to share the loads with the knee joint. The articulating ball-and-sockets allow the implant to accommodate the natural motions of the knee. The implant bases and locking screws are made of titanium alloy and the sockets are CoCrMo alloy. The compressive component of the absorber is made of polycarbonate urethane. The femoral balls, tibial balls, and the internal lining of the absorber are made of carbon-fiber-reinforced polyetheretherketone (CFR-PEEK). The implant comes in two sizes (small and large) and right or left configurations.
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