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    K Number
    K014164
    Device Name
    GREAT TOE IMPLANT SYSTEM
    Manufacturer
    HARMOS ORTHOPAEDICS, INC.
    Date Cleared
    2002-03-12

    (83 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARMOS ORTHOPAEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful MTP joint.
    Device Description
    The Great Toe Implant System is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the base of the proximal phalanx and provide a smooth articular surface for the adjacent metatarsal head. It is available in several sizes to accommodate variations in anatomy. Primary fixation is via a press fit. Materials: The devices are manufactured from CoCrMo alloy per ASTM and ISO standards, Function: The system functions to provide pain relief and improved function to the first metatarsal joint that has been damaged by inflammatory arthritis.
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