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510(k) Data Aggregation

    K Number
    K241298
    Device Name
    QUADSENSE
    Manufacturer
    Eventum Orthopaedics Ltd
    Date Cleared
    2024-10-04

    (149 days)

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

    Eventum Orthopaedics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced. For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
    Device Description
    The QUADSENSE system has been designed to allow surgeons to compare forces in the patellofemoral joint during total knee surgery. The QUADSENSE system includes a sensor that attaches to the patella, adjustment shims that attach to the sensor, a control puck, and a touchscreen Panel PC with QUADSENSE software. The patella sensor can take readings of Medial, Lateral, Superior, and Inferior loads during range of motion trials. The sensor records data that is displayed on the Panel PC in real time. The Panel PC remains outside of the sterile field, and the software workflow can be controlled by the surgeon using the control puck, within the sterile field. The Panel PC collects and temporarily stores sensor reading data so the surgeon can view the sensor readings of force through the patellofemoral joint during different stages of the surgical procedure. The sensor has been designed to attach to the patella at the start of the surgical procedure, following a conservative resection of the patella. This allows the surgeon to take a sensor reading of the patient's force through the patellofemoral joint during range of motion trials, prior to the resurfacing of the femur and the tibia. The surgeon can then take a reading of the force through the patellofemoral joint with the trial femoral and tibial components in situ. This allows the surgeon to assess how the new position of the femoral and tibial components has impacted the patient's force through the patellofemoral joint by comparing the reference reading taken prior to resurfacing to the reading(s) taken following trial implant insertion. The sensor is supplied with several shims with different thicknesses and angles. By changing the thickness, rotation angulation parameters of the shim attached to the surgical procedure the surgeon can assess how change in patella thickness or angulation will impact the force through the patellofemoral joint.
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