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510(k) Data Aggregation

    K Number
    K192279
    Device Name
    PhantomMSK Trauma
    Date Cleared
    2019-12-07

    (107 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 Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning Orthopedic Trauma 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 is not for primary image interpretation. The software is not for use on mobile phones.
    Device Description
    The PhantomMSK Trauma is a non-invasive software system that provides image analysis tools for Orthopedic Trauma procedures that use fluoroscopic imaging to assist with implant, instrument and anatomic alignment. PhantomMSK Trauma provides templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment. PhantomMSK Trauma 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 Trauma operates on image principles that are not vendor specific. To operate PhantomMSK Trauma, 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 Trauma uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and correct for fluoroscopic distortion.
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    K Number
    K182332
    Device Name
    PhantomMSK
    Date Cleared
    2019-02-15

    (171 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 is an image-processing software indicated to assist in the positioning of Total Hip Replacement components. It is intended to assist in precisely positioning Total Hip Replacements 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 is a non-invasive software system that provides image analysis tools for Total Hip Replacement procedures that use fluoroscopic imaging to assist with implant and anatomic alignment. Total Hip Replacement aims to restore native hip biomechanics, since an unstable or asymmetrical pelvic anatomy may increase the risk of postoperative complications. Several alignment considerations during Total Hip Replacement include leg length, femoral offset, cup inclination, femoral abduction, pelvic tilt and pelvic obliquity. To assist surgeons with these alignments, PhantomMSK provides templating, measurement, and distortion adaptation tools for intraoperative fluoroscopic image assessment. PhantomMSK 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 operates on image principles that are not vendor specific. To operate PhantomMSK, 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 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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