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510(k) Data Aggregation

    K Number
    K172267
    Device Name
    IRENE Thoracolumbar Fixation System
    Manufacturer
    Tianjin Zhengtian Medical Instrument Co.,Ltd.
    Date Cleared
    2018-03-06

    (222 days)

    Product Code
    NKB,MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111690
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IRENE Thoracolumbar Fixation System provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: ( ) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

    Device Description

    The proposed device consists of pedicle screws, reduction screws, titanium rods and transverse connectors in various sizes, providing immobilization and stabilization of spinal segments through bridge connection between these components. The proposed device is made of titanium alloy per ASTM F136, and is intended for single-use. The proposed device includes three sub-systems, which are named as PLATINUM 5.5M Thoracolumbar Fixation System (NS2), TITANTM 5.5mm Thoracolumbar Fixation System and PLATINUM 6.35 Thoracolumbar Fixation System (NS3), all the devices use the same material and similar design principle, there are slight differences in design and parts size among these three sub-systems which does not raise different questions of safety and effectiveness. There is no surface modification or coating. The proposed devices are supplied non-sterile. It is required to be sterilized via moist heat to reach a SAL of 106 prior to surgery. The sterilization method is presented in the instructions for use, which has been validated per ISO 17665-1.

    AI/ML Overview

    This 510(k) submission is for the IRENE Thoracolumbar Fixation System, a medical device for spinal stabilization. The submission, however, states "No clinical data is presented in this submission," therefore it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

    The document focuses on demonstrating substantial equivalence to a predicate device (Devine Spinal System K111690) based on mechanical testing and material characteristics, rather than clinical performance data against specific acceptance criteria.

    Therefore, I cannot provide the requested information from this document.

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