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510(k) Data Aggregation

    K Number
    K052746
    Device Name
    CONCORDE VBR SPINAL SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2005-10-21

    (21 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K041722
    Why did this record match?
    Device Name :

    CONCORDE VBR SPINAL SYSTEM

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

    The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

    The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

    The Concorde VBR Spinal System 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.

    The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, Expedium. Viper, and Profile).

    Device Description

    Additional components in various sizes and footprints alternative minimally invasive surgical and an approach. The Concorde VBR Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.

    AI/ML Overview

    This document is a 510(k) summary for the Concorde VBR Spinal System. It describes the device, its intended use, and indicates that performance data were submitted. However, it does not detail specific acceptance criteria or the study data proving the device meets those criteria.

    Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.

    The relevant section simply states:

    PERFORMANCE DATA:
    "Performance data were submitted to characterize the additional components of the Concorde VBR Spinal System."

    To answer your request, more detailed performance data and study reports would be needed than what is available in this 510(k) summary.

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