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510(k) Data Aggregation
K Number
K120115Device Name
ORTHOSIZE
Manufacturer
Date Cleared
2012-03-14
(61 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ORTHOSIZE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Orthosize is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the templates. Clinical judgments and experience are required to properly use the software.
Device Description
Orthosize software uses digital templates, template overlays provided by orthopedic manufacturers, to estimate the size of joints. Orthosize software allows the user to place a template over a radiographic image. The user may then select an overlay that best approximates the size of the joint in the image. The user may also translate and rotate the overlay such that it substantially matches the shape and outline of the ioint in the image. In this way, Orthosize software enables the user to estimate the size and shape of implant that most closely approximates the joint presented in the image. Orthosize also allows the user to make simple measurements.
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