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510(k) Data Aggregation
K Number
K142944Device Name
ArthroPlan Digital Templating Software
Manufacturer
Date Cleared
2014-12-16
(67 days)
Product Code
Regulation Number
892.2050Why 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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