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510(k) Data Aggregation

    K Number
    K040426
    Device Name
    TRANS1 AXIAL FIXATION SYSTEM
    Manufacturer
    TRANS1, INC.
    Date Cleared
    2004-12-17

    (302 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K002371
    Why did this record match?
    Reference Devices :

    K002371

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

    The TranS1™ Axial Fixation 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™ Axial Fixation System 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 pedicle screw systems.

    Device Description

    The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.

    AI/ML Overview

    The provided text is a 510(k) summary for the TranS1 Axial Fixation System, a medical device for spinal fixation. It does not contain information about acceptance criteria, device performance testing, or study details as outlined in your request (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

    The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, which is a regulatory pathway for lower-risk medical devices in the United States. This pathway typically focuses on functional equivalence, material equivalence, and similar intended use, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria as you've requested.

    Therefore, I cannot populate the table or answer the specific questions about device performance and study details based on the information provided. The document focuses on regulatory classification, device description, and a comparison to a predicate device for market clearance.

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