ASTM WK68696

    New Test Method for Intra-operative Impaction Durability of Intervertebral Body Fusion Devices

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    Developed by Subcommittee: F04.25 | Committee F04 | Contact Staff Manager



    WK68696

    1. Scope

    This test method covers the materials and methods to assess the ability of intervertebral body fusion devices and their associated instruments to withstand intra-operative impaction forces.


    Keywords

    Cage, IBFD, Fracture, Insertion

    Rationale

    This standard will provide a test method for manufacturers to assess the ability of their intervertebral body fusion device/inserter instrument assembly to withstand expected impact loading often applied during surgical implantation. Numerous adverse events reporting cage/instrument fracture during surgical implantation have been reported in this device area. The method will provide an ability to compare performance between intervertebral body fusion device/instrument designs.

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    06-14-2019

    Technical Contact:
    Jonathan Peck

    Status:
    Draft Under Development