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510(k) Data Aggregation

    K Number
    K162559
    Device Name
    Move Forward 3D Motion Simulation Service
    Manufacturer
    BIOMET INC.
    Date Cleared
    2017-03-31

    (198 days)

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

    BIOMET INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zimmer Biomet's Move Forward 3D Motion Simulation Service is an online image analysis service indicated for skeletally mature individuals that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data. The service can be used by uploading either CT or MR image data of hip joints. The image data is processed by Zimmer Biomet to create 3D anatomy models. These 3D models are then used to perform 3D motion simulations of the hip joint. The report also provides several calculated intersection zones that may improve the simulated range of motion. Move Forward also calculates several morphological shape parameters for each of the 3D anatomy models. The software generates an interactive report as output. Clinicians do not interact with the image analysis software directly. The image analysis software is only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons. The Move Forward 3D Motion Service is intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
    Device Description
    The Move Forward 3D Motion Simulation Service is an online image analysis service that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data. This service consists of three modules: CGOnline, Arbiter, and Articulis. During the segmentation process, 3D bone models of the pelvis and femur bones are created from the image data. Any required editing of the segmentation images are performed by Zimmer Biomet operators. These 3D bone models are then used to perform 3D motion simulations of the hip joint. The 3D motion simulations can be used to visualize rigid shapes such as bones that come into contact with one another, thus potentially limiting range of motion. The system includes several calculated intersection zones that each individually improve the simulated range of motion. The system also calculates several morphological shape parameters for each of the 3D bone models. The software generates an interactive PDF report as output, which Zimmer Biomet delivers to clinicians on a per case basis through the CGOnline module. In particular, the report that is generated provides information to the clinicians associated with femoroacetabular impingement (FAI). Clinicians do not interact with the image analysis software directly. The Articulis and Arbiter modules are only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
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