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ASTM International - ASTM F2694-07

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

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Organization: ASTM International
Publication Date: 1 December 2007
Status: inactive
Page Count: 9
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
significance And Use:

Total Facet Prosthesis Components-The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating... View More

scope:

1.1 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.

1.2 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 an S-N characterization.

1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice.

1.4 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.

1.5 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.

Document History

October 1, 2020
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to: ball-and-socket articulating...
December 1, 2016
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating...
March 1, 2013
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
5.1 Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating...
ASTM F2694-07
December 1, 2007
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
Total Facet Prosthesis Components—The total facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball and socket articulating joints,...
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