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    K Number
    K252755

    Validate with FDA (Live)

    Device Name
    POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
    Manufacturer
    Point Robotics MedTech, Inc.
    Date Cleared
    2026-01-23

    (147 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K241130,K202320
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    "POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

    "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

    The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae (or T1-S1 vertebrae when used with the "POINT" Kinguide RobotArm), and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

    Device Description

    "POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

    Kinguide Agile system is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Kinguide Agile system is indicated for any medical condition in which the use of stereotactic spinal surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to the digital markers of medical images (e.g. 3D C-arm) of the anatomy.

    Kinguide RobotArm is compatible with Kinguide Agile Software version 15.0.0 or above.

    Kinguide RobotArm consists of a RobotArm Station, a Guiding Tool Set and single use accessories.

    AI/ML Overview

    N/A

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