1. Scope
1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies having integrated fixation components which anchor to the adjacent vertebral bodies, designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of the mechanical performance of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method does not purport to provide performance standards for intervertebral body fusion device assemblies. 1.3 This test method describes static and dynamic tests by specifying load types and specific methods of applying these loads. Guidelines are established for measuring displacements, determining the yield load or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies. 1.4 This test method does not address anterior expulsion testing of intervertebral body fusion device assemblies (see X1.4) 1.5 Some intervertebral body fusion device assemblies may not be testable in all test configurations. 1.6 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. 1.7 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 (F 2077) 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 labs, and the US FDA.
Keywords
spine; spinal implants; orthopaedic; static test methods; dynamic test methods;
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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