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    K Number
    K192778
    Device Name
    Kinos Axiom Total Ankle System
    Manufacturer
    Kinos Medical
    Date Cleared
    2020-06-30

    (274 days)

    Product Code
    HSN
    Regulation Number
    888.3110
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    Applicant Name (Manufacturer) :

    Kinos Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Axiom Total Ankle System is intended for cement use only.
    Device Description
    The subject Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain and providing flexion-extension movement within the ankle joint. The device is intended to be used with bone cement. The subject Kinos Axiom Total Ankle System comprises three implant components – a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibial-talar joint.
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