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510(k) Data Aggregation

    K Number
    K241870
    Device Name
    OnPoint Augmented Reality Spine System
    Date Cleared
    2024-08-19

    (53 days)

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

    OnPoint Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy. The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, pared with optional targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracked instrument location including deviation from plan. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
    Device Description
    The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared track to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To quide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor: - Target position and orientation of the instrument path - Current position and orientation of the instrument - Cross sectional images - 3D model of the patient's spine Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surgeon to define the target position and orientation as well as the length and diameter of the pedicle screws.
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    K Number
    K231284
    Device Name
    OnPoint Augmented Reality Spine System
    Date Cleared
    2023-09-08

    (128 days)

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

    OnPoint Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy. The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
    Device Description
    The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared tracking technology is used to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To guide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor: - . Target position and orientation of toolpath - . Current position and orientation of instrument - . Cross sectional images - . 3D model of the patient's spine Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surqeon to define the target position and orientation as well as length and diameter of the pedicle screws. The OnPoint Augmented Reality Spine System consists of the following components: - Tracking camera, workstation, and cart ● - . Headsets with supplemental battery - . Software - Tracked instruments and adapters ●
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