Spinal Implants

These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies. These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly.

This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment. 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 intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.

This guide covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. The purpose of this guide is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this guide to address the analysis of spinal implant constructs or sub constructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the

Consequences of the use of particular spinal implant designs.