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510(k) Data Aggregation

    K Number
    K122901
    Device Name
    FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
    Manufacturer
    ORTHOFIX
    Date Cleared
    2012-12-03

    (73 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K081684,K082797,K092624,K100044
    Predicate For
    K130176,K130932,K132603,K153323,K161516,K200303
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

    • degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
    • spondylolisthesis,
    • trauma (i.e., fracture or dislocation),
    • spinal stenosis,
    • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
    • tumor,
    • pseudoarthrosis, and
    • failed previous fusion.

    The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

    The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    Device Description

    The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The components include rods, screws, screw bodies, offset head, lateral offsets, and connectors. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.

    The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

    AI/ML Overview

    This document is a 510(k) summary for the Orthofix Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML-driven medical device.

    Therefore, I cannot provide the requested information because the provided text does not describe an AI/ML-driven device or its performance studies. It describes a spinal fixation system, which is a physical implant.

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