ASTM WK34549

    Work Item: ASTM WK34549 - New Guide for Evaluating Intervertebral Body Fusion Devices with Integrated Fixation Components

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



    1. Scope

    1.1 This guide describes methods for the static and dynamic testing of intervertebral body fusion device assemblies having integrated components that anchor the device to the adjacent vertebral bodies. These assemblies may be used in different intended spinal locations with different methods of application to the intradiscal space. All these devices are designed to promote arthrodesis at a given spinal motion segment. These devices are a specialized form of those addressed in Test Methods F2077. 1.2 This guide is intended to assist in making mechanical comparisons among past, present, and future nonbiologic intervertebral body fusion device assemblies. This guide describes static and dynamic tests of various load types and methods of applying these loads. Guidelines are suggested for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies. 1.3 This guide does not purport to provide performance standards for intervertebral body fusion device assemblies nor does it address all possible modes of implant or surgical technique failure. An engineering design risk analysis should be performed to assess all possible patient and surgeon harms and device failures. This guide may provide test methods applicable to some of those design risks. 1.4 Some intervertebral body fusion device assemblies may not be testable in all test configurations. 1.5 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    The current standard for intervertebral fusion devices (F2077) does not include devices with additional fixation features, such as screws. The past three ASTM F04.25 sessions have included discussion about the need for a standard addressing these devices and what it might entail. A consensus has been reached about the need for such a standard and a rough outline of its form, by device manufacturers, test laboratories, and the U.S. FDA.


    Keywords

    dynamic test methods; intervertebral body fusion device; spinal implants; static test methods

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

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    Work Item Status

    Date Initiated:
    08-29-2011

    Technical Contact:
    Andrew Dooris

    Item:
    001

    Ballot:
    F04.25 (14-01)

    Status:
    Negative Votes Need Resolution