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    K Number
    K243537
    Device Name
    XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
    Manufacturer
    XELITE BIOMED LTD.
    Date Cleared
    2025-04-11

    (147 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K241775
    Why did this record match?
    Device Name :

    XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

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

    The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).

    Device Description

    XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system.

    Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.

    The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.

    AI/ML Overview

    This FDA clearance letter pertains to a bone cement system and its delivery system, not an AI/ML powered device. As such, the typical acceptance criteria and study descriptions relevant to AI/ML devices (e.g., sensitivity, specificity, MRMC studies, expert adjudication) are not present in this document.

    The provided text focuses on the substantial equivalence of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement System to a predicate device, primarily based on its materials, indications for use, and pre-clinical testing for the delivery system.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information presented is for a traditional medical device (bone cement and its delivery system).

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