5.1 Occipital-cervical and occipital-cervical-thoracic spinal implants are generally composed of several components which, when connected together, form either an occipital-cervical spinal implant assembly or an occipital-cervical-thoracic spinal implant assembly. Occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are designed to provide some stability to the spine during the process of arthrodesis. These test methods outline standard materials and methods for the evaluation of different spinal implant assemblies to facilitate comparisons between different designs.

5.2 These test methods are used to quantify the static and dynamic mechanical characteristics of different designs of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. The mechanical tests are conducted in vitro using simplified load schemes and do not attempt to mimic the complex loads of the occipital-cervical and occipital-cervical-thoracic spine.

5.3 The loads applied to the spinal implant assemblies in vivo will, in general, differ from the loading configurations used in these test methods. The results obtained here cannot be used directly to predict in vivo performance. The results can be used to compare different component designs in terms of the relative mechanical parameters.

5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be initially performed dry (ambient room conditions) for consistency. The effect of the environment may be significant. Repeating all or part of these test methods in simulated body fluid, saline (9 g NaCl per 1000 mL water), a saline drip, water, or a lubricant should be considered. The maximum recommended frequency for this type of cyclic testing should be 5 Hz.

5.5 The location of the longitudinal elements is determined by the intended in vivo location of the anchors. The perpendicular distance to the load direction between the axis of a hinge pin and the anchor's attachment points to a polyacetal block is independent of anchor-type for the cervical block, but dependent on the design for the occipital test block. The distance between the polyacetal block and the center of the longitudinal element is a function of the design of the implant.