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510(k) Data Aggregation

    K Number
    K073514
    Device Name
    TRANS1 AXIAL FIXATON SYSTEM
    Manufacturer
    TRANS1 INCORPORATED
    Date Cleared
    2008-01-11

    (28 days)

    Product Code
    KWQ,HRX,KWO
    Regulation Number
    888.3060
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K050965,K040426
    Why did this record match?
    Device Name :

    TRANS1 AXIAL FIXATON SYSTEM

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

    The TranS1® AxiaLiF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.

    The intended use of the instrumentation kit is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5 - S1 interbody fusion.

    Device Description

    The TranS1® AxiaLIF® System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 -- S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding acceptance criteria, study details, or device performance metrics. The document consists of a 510(k) summary for the TranS1® AxiaLIF® Fixation System, primarily detailing its intended use, device description, and substantial equivalence to predicate devices, along with the FDA's clearance letter.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and data provenance
    3. Number of experts used to establish ground truth and their qualifications
    4. Adjudication method
    5. MRMC comparative effectiveness study details
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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