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510(k) Data Aggregation

    K Number
    K041205
    Device Name
    EXPEDIUM ANTERIOR SPINE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2004-08-17

    (102 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K012916
    Predicate For
    K102406,K131802
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Expedium™ Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures.

    The Expedium Anterior Spine System is indicated for:

    1. degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
    2. spondylolisthesis
    3. trauma (i.e., fracture or dislocation)
    4. spinal stenosis
    5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
    6. tumor
    7. pseudarthrosis
    8. previous failed fusion
    Device Description

    The Expedium Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The implants of the Expedium Anterior Spine System have been designed for use in either open or thoracoscopic approaches. Manufactured from ASTM F-136 implant grade titanium alloy.

    AI/ML Overview

    The provided text is a 510(k) summary for the Expedium™ Anterior Spine System, a medical device. It does not include information about acceptance criteria, device performance metrics, or study design details that would typically be found in a performance study report.

    Specifically, the "Performance Data" section in the 510(k) summary (page 1, section PERFORMANCE DATA) simply states: "Performance data were submitted to characterize the [device]." It does not elaborate on what that data entails, the criteria used to evaluate it, or the results.

    Therefore, none of the requested information (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, or ground truth establishment for training set) can be extracted from the provided document.

    This document is a regulatory submission summary, primarily focused on describing the device, its intended use, and establishing substantial equivalence to a predicate device, rather than detailing the results of performance studies.

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