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510(k) Data Aggregation

    K Number
    K251737
    Date Cleared
    2025-09-04

    (90 days)

    Product Code
    Regulation Number
    882.4560
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NextAR Shoulder™ Platform supports the surgeon during glenoid implantation in anatomic and reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.

    The NextAR Shoulder™ Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System shoulder prosthesis.

    As an optional display, the smart glasses can be used auxiliary to the NextAR Shoulder™ Platform to view the same 2D stereotaxic information as presented by the NextAR Shoulder™ Platform.

    The NextAR Shoulder™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical procedures by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR™ stereotaxic instruments provide reference to a patient’s rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning.

    The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

    Device Description

    The NextAR™ Shoulder Platform is a CT based computer-assisted surgical navigation platform used to perform a total shoulder arthroplasty on the glenoid and includes the following components:

    • PC based hardware platform; (K210153)
    • Optical tracking system; (K210153)
    • Augmented Reality glasses; (K210153)
    • Platform (K210153)
    • navigation software which displays information to the surgeon in real-time;
    • Reusable surgical instruments to perform the surgical steps of a shoulder arthroplasty on the glenoid.

    The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers. Tracking sensors attached to the scapula and surgical instruments enable the surgeon to register the position and orientation of scapula and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.

    NextAR™ Shoulder Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.

    The NextAR™ Shoulder system is intended to assist the surgeon in executing a preoperative surgical planning. The navigation platform tracks the surgical instruments in real-time and displays intraoperative and planned surgical parameters on a screen, thus allowing the surgeon to match the intraoperative parameters with the planned ones.

    Specifically, the navigation system utilizes established technologies of navigation and via an active infrared camera rigidly coupled with the scapula and an active infrared tracker that can be rigidly coupled to the surgical instruments. The registration of the patient's scapula on the preoperative scapula model is performed through the use of dedicated surgical instruments (pointers) and a dedicated registration algorithm.

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