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    K Number
    K070786
    Device Name
    X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
    Manufacturer
    THEKEN SPINE LLC
    Date Cleared
    2007-06-28

    (98 days)

    Product Code
    MQP,PAN
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K983622,K041592,K050058,K003155,K012254,K003836
    Why did this record match?
    Device Name :

    X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT

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

    The x•POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).

    The x•POD Adjustable Vertebral Body Replacement is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.

    The x•POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).

    Device Description

    The x•POD Adjustable Vertebral Body Replacement is comprised of a cylindrical titanium (Ti-6Al-4V) mechanism with rectangular endplates. The system has fenestrations axially and laterally to maximize bone graft placement. The implants are manufactured in a variety of geometric combinations to better fit each patient's pathology. The anatomically designed endplates are designed to minimize expulsion and rotation of the implant postoperatively. The x•POD Adjustable Vertebral Body Replacement is manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 standards. The x•POD Adjustable Vertebral Body Replacement construct is used individually and is always implanted with the construct oriented vertically.

    AI/ML Overview

    This is a 510(k) premarket notification for a spinal implant device (x•POD Adjustable Vertebral Body Replacement), not a diagnostic AI device. Therefore, the provided text does not contain information about acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the approval process for this type of medical device.

    The approval is based on "substantial equivalence" to legally marketed predicate devices, meaning it has similar intended use, design, and physical characteristics, and performs comparably in mechanical testing, not through clinical performance metrics like sensitivity or specificity.

    Therefore, I cannot provide the requested information.

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