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510(k) Data Aggregation

    K Number
    K252847

    Validate with FDA (Live)

    Date Cleared
    2026-01-09

    (123 days)

    Product Code
    Regulation Number
    882.4560
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K250477

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NextAR Hip is intended to support the surgeon during Total Hip Arthroplasty (THA) procedures by providing navigational information during bone preparation and positioning of acetabular cup components in skeletally mature individuals during supine or lateral approaches.

    NextAR Hip is indicated for use with Medacta hip prosthesis as described in the implants' instruction for use. NextAR Hip provides stereotaxic guidance in reference to a patient's rigid anatomy as registered in CT based or imageless workflows.

    As an optional display, the smart glasses can be used auxiliary to the NextAR Hip to view the same information as presented by the NextAR Hip. NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

    Device Description

    The NextAR Hip Platform is a computer-assisted surgical navigation platform used to support the surgeon during implantation in hip replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.

    The NextAR Hip Platform consists of three components:

    • NextAR hardware (composed of NextAR Control Unit, NextAR Tracking System and NextAR Smart Glasses);
    • NextAR Hip Software; and
    • NextAR Hip stereotaxic instruments.

    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 target. Tracking sensor attached to the pelvis and surgical instruments enable the surgeon to register the position and orientation of the patient's anatomy and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking system is provided sterile.

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

    AI/ML Overview

    N/A

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