ASTM F2694-07(2013)
Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

Standard No.

ASTM F2694-07(2013)

Release Date

2007

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2694-16

Latest

ASTM F2694-16(2020)

Scope

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 be 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.

Note 1—This setup would require two rotational actuators and one translational actuator.

FIG. 1 Diagrams of Possible Test Apparatus for Allowing Simultaneous Lateral Bending and Axial Rotation Motions with Anterior-Posterior Directed Facet Loading

Note 1—This setup would require two rotational actuators and one translational actuator
.

FIG. 2 Diagrams of Possible Test Apparatus for Allowing Simultaneous Flexion-Extension and Lateral Bending Motions with Anterior-Posterior Directed Facet Loading

5.2.5 Load and Motion:

ASTM F2694-07(2013) history

• 2020 ASTM F2694-16(2020) Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• 2016 ASTM F2694-16 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• 2007 ASTM F2694-07(2013) Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• 2007 ASTM F2694-07 Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses