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510(k) Data Aggregation

    K Number
    K163338
    Device Name
    OMNIBotics Knee System
    Manufacturer
    OMNllife Science Inc.
    Date Cleared
    2017-09-01

    (277 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNllife Science Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OMNIBotics® Knee System is indicated for stereotaxic surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants.
    Device Description
    The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting guide that is used by surgeons and OR staff to assist in performing stereotaxic total knee arthroplasty (TKA). The OMNIBotics® Knee System consists of the OMNIBotics® Station, ART Knee Application software, the iBlock® cutting guide for guiding femoral bone resections, and the Active Spacer, an active (motorized) knee spacer and ligament tensioning device for knee ligament balancing. The OMNIBotics® Station includes a 3D optoelectronic localizer mounted on an articulated arm, a laptop hosting the ART Knee Software and equipped with a touchscreen, an external LCD monitor and a three-button footswitch as a means for the user to interact with the system. The power supply and communication hardware required for the camera, the iBlock® and the Active Spacer are contained within a single enclosure, the control box, located at the base of the Station.
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