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510(k) Data Aggregation

    K Number
    K142944
    Device Name
    ArthroPlan Digital Templating Software
    Manufacturer
    Date Cleared
    2014-12-16

    (67 days)

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

    Arthromeda, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ArthroPlan™ is indicated for use by suitably licensed and qualified healthcare professionals requiring access to medical images to be used in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the size and geometry of the prosthetic/fixation device when planning a potential hip arthroplasty surgical procedure. Templating is done without alteration of the original image, using scaling and measurement tools in a digital environment, in conjunction with manufacturers' templates available via the ArthroPlan library of digital templates for prosthetic and fixation devices.
    Device Description
    ArthroPlan™ is software designed and developed for preoperative planning, a.k.a. digital templating, for orthopedic operations. It includes tools for performing common measurements and drawings in combination with orthopedic implant manufacturer's electronic templates (provided in the ArthroPlan Template Library, which is part of the software). The measurements and scaling tools enable the user performing preoperative planning for orthopedic procedures. - The software allows the user to capture the radiographic image, import it to the software, accurately scale the degree of maqnification of the image, and overlay and manipulated (size, angle, rotate, invert, etc.) the desired electronic template(s) on the image facilitating the election of the appropriate size of prosthetic/fixing.
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