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510(k) Data Aggregation

    K Number
    K010322
    Device Name
    ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
    Manufacturer
    ORTHODYNE, INC.
    Date Cleared
    2001-05-02

    (89 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHODYNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISKD System intended for limb lengthening of the femur and tibia. The ISKD is indicated for limb lengthening of the tibia and femur.
    Device Description
    The ISKD System is an intramedullary limb lengthening system that provides gradual, controlled osteogenic distraction of the tibia and femur. The ISKD System consists of the telescoping internal limb lengthening device, titanium locking screws, instrumentation and an external handheld Monitor. As the patient performs rotational oscillations of the affected limb during normal ambulation, the ISKD distracts as the distal section of the implant gradually telescopes out of the proximal section. The the implant is controlled by a one-way clutch mechanism and a threaded and. A small magnet sealed within the ISKD implant rotates simultaneously as the implant distracts. The hand-held external Monitor is similar to an electronic compass and communicates with the magnet by detecting and tracking changes in the magnet poles. The external Monitor enables both trationing and physicians to monitor the daily limb lengthening progress. Titanium locking screws (2 proximal and 2 distal) secure the device in place in the intramedullary canal.
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