Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
|Publication Date:||1 December 2016|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This practice provides guidance for the functional, kinematic, and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets.
This test method is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating a Stress-Life (S-N) characterization.
Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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.
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.