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510(k) Data Aggregation

    K Number
    K232176
    Device Name
    STELLAR Knee
    Manufacturer
    Date Cleared
    2023-11-02

    (104 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    PolarisAR Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    STELLAR Knee is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. STELLAR Knee is indicated for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The STELLAR Knee is installed on a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.
    Device Description
    The main purpose of the STELLAR Knee is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. STELLAR Knee includes software and surgical instruments. STELLAR Knee uses established surgical navigation techniques to provide information to help track patient bony landmarks in real time to assist the surgeon in determining resection angles and measurements as required in knee replacement surgery. STELLAR Knee allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the surgical instruments. The software locates in a 3D reference frame the instruments which include marker arrays. All collected coordinates are treated by software algorithms to provide the surgeon with the relevant orientation of the tracked cutting quide. STELLAR Knee software is installed on a wearable Head Mounted Device (HMD) which includes an embedded camera and displays intraoperative information to the user. This near-eye display allows the surgeon to look at the HMD screen or the field of view when needed.
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