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    K Number
    K932330
    Device Name
    TI-6AL-7NB URTN
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1996-03-08

    (1030 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TI-6AL-7NB URTN

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

    Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.

    Device Description

    Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.

    AI/ML Overview

    This document describes a medical device, the Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail, and its sterilization validation, not the performance of an AI or diagnostic device that would typically have acceptance criteria related to accuracy or other performance metrics.

    Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC study, standalone performance, training set details) are not applicable to this document.

    This document focuses on:

    • Device Description: A tibial nail for stabilizing fractures.
    • Material: Titanium-6Aluminum-7Niobium.
    • Sterilization Method: Gamma radiation.
    • Sterilization Validation: Biological Indicator - Overkill Method, following AAMI guidelines, ensuring a sterility assurance level in excess of 10^-6.
    • Packaging: Double sterility barrier using PETG plastic trays and Tyvek lids.
    • Radiation Dose: 2.5 - 3.2 MegaRads (validation minimum dose range per AAMI is 1.8 - 2.6 MegaRads).
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