ASTM F2694-16

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

SIGNIFICANCE AND USE
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 joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may have a unilateral or bilateral design.  
5.2 Spinal Testing Apparatus:  
5.2.1 Test Chambers—In case of a multispecimen machine, each chamber shall be isolated to prevent cross-contamination of the test specimens. The chamber shall be made entirely of corrosion-resistant materials, such as acrylic plastic or stainless steel, and shall be removable from the machine for thorough cleaning between tests.  
5.2.2 Component Clamping/Fixturing—Since the purpose of the test is to characterize the wear and kinematic function of the total facet prosthesis, the method for mounting components in the test chamber shall not compromise the accuracy of assessment of the weight loss or stiffness variation during the test. For example, prostheses having complicated superior and inferior surfaces for contacting bone (for example, sintered beads, hydroxylapatite (HA) coating, plasma spray) may be specially manufactured to modify that surface in a manner that does not affect the wear simulation.  
5.2.3 The device should be securely (rigidly) attached at its bone-implant interface to the mating test fixtures.  
5.2.4 The motion of the superior test fixture (more posterior fixture in Figs. 1 and 2) relative to the inferior testing fixture shall be constrained in three-dimensional space except for the components in the direction of specified test motions/loads. .  
5.2.5 Load and Motion:  
5.2.5.1 Facet loads (fx) are initially applied in the direction of the positive X-axis.
5.2.5.2 Flexion load and motion are positive moment and rotation about the Y-axis.
5.2.5.3 Extension load and motion are negative moment and rotation about...
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 a Stress-Life (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 standard. No other units of measurement are included in this standard.  
1.4.1 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.

General Information

• Status: Historical
• Publication Date: 30-Nov-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.25 - Spinal Devices

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2694 − 16
Standard Practice for
Functional and Wear Evaluation of Motion-Preserving
1
Lumbar Total Facet Prostheses
This standard is issued under the fixed designation F2694; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Used in Total Joint Prostheses
F1714 GuideforGravimetricWearAssessmentofProsthetic
1.1 This practice provides guidance for the functional,
Hip Designs in Simulator Devices
kinematic, and wear testing of motion-preserving total facet
F1877 Practice for Characterization of Particles
prostheses for the lumbar spine.These implants are intended to
F2346 Test Methods for Static and Dynamic Characteriza-
allow motion and lend support to the functional spinal unit(s)
tion of Spinal Artificial Discs
through replacement of the natural facets.
F2423 Guide for Functional, Kinematic, and Wear Assess-
1.2 This test method is not intended to address the bone
ment of Total Disc Prostheses
implant interface or the static characteristics of the prosthesis
components. Fatigue characteristics are included, but only as a
3. Terminology
by-product of cyclic wear testing under facet load and thus are
3.1 All functional and kinematic testing terminology is
not addressed in the typical process of generating a Stress-Life
consistent with the referenced standards, unless otherwise
(S-N) characterization.
stated.
1.3 Biocompatibility of the materials used in a total facet
3.2 Definitions of Terms:
prosthesis are not addressed in this practice.
3.2.1 mechanical failure, n—failure associated with a defect
1.4 The values stated in SI units are to be regarded as
in the material (for example, fatigue crack) or of the bonding
standard. No other units of measurement are included in this
between materials that may or may not produce functional
standard.
failure. F2423
1.4.1 The values stated in SI units are to be regarded as the
3.2.2 run out (cycles), n—maximum number of cycles that a
standard with the exception of angular measurements, which
test needs to be carried to if functional failure has not yet
may be reported in either degrees or radians.
occurred. F2423
1.5 This standard does not purport to address all of the
3.3 Definitions of Terms Specific to This Standard:
safety concerns, if any, associated with its use. It is the
3.3.1 coordinate systems/axes, n—global XYZ orthogonal
responsibility of the user of this standard to establish appro-
axes are defined following a right-handed Cartesian coordinate
priate safety and health practices and determine the applica-
system in which the XY plane is parallel to and co-planar with
bility of regulatory limitations prior to use.
the superior endplate of the inferior vertebral body. The global
axes are fixed relative to the inferior vertebral body, which in
2. Referenced Documents
this practice is also considered to be stationary with respect to
2
2.1 ASTM Standards:
thetestmachine’sframe.Lowercaseletters, xyz,denotealocal
F561 Practice for Retrieval and Analysis of Medical
moving orthogonal coordinate system attached to the superior
Devices, and Associated Tissues and Fluids
vertebral body with directions initially coincident with those of
F732 Test Method for Wear Testing of Polymeric Materials
the global XYZ axes, respectively. The 3D motion of the
superiorrelativetotheinferiorvertebraisspecifiedandistobe
measured in terms of sequential Eulerian angular rotations
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
about the xyz axes, respectively (z axial rotation, x lateral bend,
Surgical Materials and Devices and is the direct responsibility of Subcommittee
and y flexion-extension).
F04.25 on Spinal Devices.
Current edition approved Dec. 1, 2016. Published January 2017. Originally
3.3.1.1 origin, n—center of the global coordinate system
approved in 2007. Last previous edition approved in 2013 as F2694– 07 (2013).
that is located at the posterior medial position on the superior
DOI: 10.1520/F2694-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
endplate of the inferior vertebral body.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3.3.1.2 X-axis, n—positive X-axisistobedirectedanteriorly
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. relative to the specimen’s initial unloaded position.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2694 − 16
3.3.1.3 Y-axis, n—positive Y-axis is directed laterally (to
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2694 − 07 (Reapproved 2013) F2694 − 16
Standard Practice for
Functional and Wear Evaluation of Motion-Preserving
1
Lumbar Total Facet Prostheses
This standard is issued under the fixed designation F2694; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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 a Stress-Life (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 standard. No other units of measurement are included in this standard.
1.4.1 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1877 Practice for Characterization of Particles
F2346 Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
F2423 Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
3. Terminology
3.1 All functional and kinematic testing terminology is consistent with the referenced standards, unless otherwise stated.
3.2 Definitions of Terms:
3.2.1 mechanical failure, n—failure associated with a defect in the material (for example, fatigue crack) or of the bonding
between materials that may or may not produce functional failure. F2423
3.2.2 run out (cycles), n—maximum number of cycles that a test needs to be carried to if functional failure has not yet occurred.
F2423
3.3 Definitions:Definitions of Terms Specific to This Standard:
3.3.1 coordinate systems/axes, n—global XYZ orthogonal axes are defined following a right-handed Cartesian coordinate system
in which the XY plane is parallel to and co-planar with the superior endplate of the inferior vertebral body. The global axes are
fixed relative to the inferior vertebral body, which in this practice is also considered to be stationary with respect to the test
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.25
on Spinal Devices.
Current edition approved March 1, 2013Dec. 1, 2016. Published March 2013January 2017. Originally approved in 2007. Last previous edition approved in 20072013 as
F2694—07. DOI: 10.1520/F2694-07R13.– 07 (2013). DOI: 10.1520/F2694-16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2694 − 16
machine’s frame. Lower case letters, xyz, denote a local moving orthogonal coordinate system attached to the superior vertebral
body with directions initially coincident with those of the global XYZ axes, respectively. The 3D motion of the superior relative
to the inferior vertebra is specified and is to be measured in terms of sequential Eulerian angular rotations about the xyz
...