1. Scope
1.1 This guide describes the various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices. 1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in this guide. However, the user should investigate the biocompatibility of their device separately (see X1.1). 1.3 While it is understood that expulsion and endplate fractures represent documented clinical failures, this guide does not specifically address them, although some of the factors that relate to expulsion have been included (see X1.3). 1.4 Some nucleus devices may not be stable in all test configurations. 1.5 It has not been demonstrated that mechanical failure of nucleus devices is related to adverse clinical results. Therefore, this guide should be used with care in evaluating proposed nucleus devices. 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 either degrees or radians. 1.7 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the nucleus device under evaluation. 1.8 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 to determine the applicability of regulatory limitations prior to use.
This standard is necessary for the preclinical testing of nucleus. It will be used by the manufacturers in the testing of these devcies and the FDA in evaluating these tests.
Keywords
nucleus device; spinal implants; static tests; dynamic tests
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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