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510(k) Data Aggregation

    K Number
    K210136
    Device Name
    PhantomMSK Hip
    Date Cleared
    2021-02-18

    (30 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    OrthoGrid Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PhantomMSK Hip is an image-processing software indicated to assist in the positioning of Total Hip Replacement and Hip Preservation components. It is intended to assist in precisely positioning Total Hip Replacement and Hip Preservation components intraoperatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device. The device is not for primary image interpretation. The software is not for use on mobile phones.
    Device Description
    The PhantomMSK Hip is a non-invasive software system that provides image analysis tools for Total Hip Replacement and Hip Preservation procedures that use fluoroscopic imaging to assist with implant and anatomic alignment. PhantomMSK Hip provides templating, measurement, and distortion adaptation (correction) tools for intraoperative fluoroscopic image assessment. PhantomMSK Hip does not include any custom computer hardware and is a software-based device that can be run on a "commercial off-the-shelf" system (i.e. PC, keyboard, mouse, touchscreen monitor etc.) that meet minimum performance requirements. Furthermore, PhantomMSK Hip operates on image principles that are not vendor specific. To operate PhantomMSK Hip, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion. Fluoroscopic distortion is attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor. The PhantomMSK Hip uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and adapt for fluoroscopic distortion.
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