ASTM F2624-12(2016)

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

ABSTRACT
This test method deals with static, dynamic, and wear testing of extra-discal motion preserving implants. These implants are intended to augment spinal stability without significant tissue removal while allowing motion of the functional spinal unit(s). Wear is assessed using a weight loss method and a dimensional analysis for determining wear of components used in extra-discal spinal motion preserving procedures, using testing medium as defined in this test method. This test method is not intended to address facet arthroplasty devices and any potential failure mode as it relates to the fixation of the device to its bony interfaces; and does not prescribe methods for assessing the mechanical characteristics of the device in translation. The static test includes the static flexion test, static extension test, static torsion test, static lateral bending test, and fatigue tests. Wear test includes flexion/extension wear assessment, rotational wear assessment, and bending wear assessment. The apparatus which shall be used includes implant components and spinal testing apparatus. The calculation and interpretation of wear results are also elaborated.
SIGNIFICANCE AND USE
4.1 This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37°C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.  
4.2 This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs (See Fig. 2, Fig. 4, and Fig. 5). See also Table 1.Figure  
Loading Mode  
Rotational  
Fig. 2  
Flexion  
Extension  
Lateral Bending  
Axial Rotation  
Fig. 2 and Fig. 6  
Offset Flexion and Offset Extension  
Shear  
Fig. 4  
Anterior/Posterior Shear  
Compression Bending  
Fig. 5  
Compression Bending  
4.3 Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.
SCOPE
1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs.  
1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).  
1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces.  
1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.  
1.5 This test method is not intended to address facet arthroplasty devices.  
1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting.  
1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather this method provides useful bo...

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: F2624 − 12 (Reapproved 2016)
Standard Test Method for
Static, Dynamic, and Wear Assessment of Extra-Discal
1
Single Level Spinal Constructs
This standard is issued under the fixed designation F2624; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope device design. In most instances, only a subset of the herein
described test methods will be required.
1.1 This test method describes methods to assess the static
and dynamic properties of single level spinal constructs. 1.10 The values stated in SI units are to be regarded as the
standard with the exception of angular measurements, which
1.2 Anoptionforassessingwearusingaweightlossmethod
may be reported in either degrees or radians. No other units of
and a dimensional analysis is given. This method, described
measurement are included in this standard.
herein, is used for the analysis of devices intended for motion
1.11 This test method does not purport to address all of the
preservation, using testing medium as defined in this standard
safety concerns, if any, associated with its use. It is the
(6.1).
responsibility of the user of this test method to establish
1.3 Thistestmethodisnotintendedtoaddressanypotential
appropriate safety and health practices and to determine the
failuremodeasitrelatestothefixationofthedevicetoitsbony
applicability of regulatory limitations prior to use.
interfaces.
1.4 It is the intent of this test method to enable single level
2. Referenced Documents
extra-discal spinal constructs with regard to kinematic,
2
2.1 ASTM Standards:
functional, and wear characteristics when tested under the
E2309Practices forVerification of Displacement Measuring
specified conditions.
Systems and Devices Used in Material Testing Machines
1.5 This test method is not intended to address facet
F561 Practice for Retrieval and Analysis of Medical
arthroplasty devices.
Devices, and Associated Tissues and Fluids
F1714GuideforGravimetricWearAssessmentofProsthetic
1.6 In order that the data be reproducible and comparable
Hip Designs in Simulator Devices
within and between laboratories, it is essential that uniform
F1717Test Methods for Spinal Implant Constructs in a
procedures be established. This test method is intended to
Vertebrectomy Model
facilitate uniform testing methods and data reporting.
F1877Practice for Characterization of Particles
1.7 The motion profiles specified by this test method do not
F2003Practice for Accelerated Aging of Ultra-High Mo-
necessarily accurately reproduce those occurring in vivo.
lecular Weight Polyethylene after Gamma Irradiation in
Rather this method provides useful boundary/endpoint condi-
Air
tions for evaluating implant designs in a functional manner.
F2423Guide for Functional, Kinematic, and Wear Assess-
1.8 This test method is not intended to be a performance
ment of Total Disc Prostheses
standard. It is the responsibility of the user of this test method
to characterize the safety and effectiveness of the device under 3. Terminology
evaluation.
3.1 All terminology is consistent with the referenced
1.9 Multiple test methods are included in this standard. standards, unless otherwise stated.
However, it must be noted that the user is not obligated to test
3.2 Definitions:
using all of the described methods. Instead, the user should
3.2.1 center of rotation (COR)—the point about which the
only select test methods that are appropriate for a particular
simulated vertebral bodies rotate in performing the range of
motion (ROM) specified in this test method.
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF04onMedical
andSurgicalMaterialsandDevicesandisthedirectresponsibilityofSubcommittee
2
F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2016. Published December 2016. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2007. Last previous edition approved in 2012 as F2624–12. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2624-12R16. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2624 − 12 (2016)
FIG. 1 Typical Force Displacement Curve
3.2.2 compressive bending stiffness (N/mm)—the compres- 3.2.5.2 X-Axis—the positive X-Axis is a global fixed axis
sive bending yield force divided by elastic displacement (see
relative to the testing machine’s stationary base and is to be
the initial slope of li
...

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: F2624 − 12 F2624 − 12 (Reapproved 2016)
Standard Test Method for
Static, Dynamic, and Wear Assessment of Extra-Discal
1
Single Level Spinal Constructs
This standard is issued under the fixed designation F2624; 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 test method describes methods to assess the static and dynamic properties of single level spinal constructs.
1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein,
is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard (6.1).
1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony
interfaces.
1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional,
and wear characteristics when tested under the specified conditions.
1.5 This test method is not intended to address facet arthroplasty devices.
1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures
be established. This test method is intended to facilitate uniform testing methods and data reporting.
1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo. Rather
this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner.
1.8 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to
characterize the safety and effectiveness of the device under evaluation.
1.9 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using
all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design.
In most instances, only a subset of the herein described test methods will be required.
1.10 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. No other units of measurement are included in this standard.
1.11 This test method 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 test method to establish appropriate safety and health practices and to determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E2309 Practices for Verification of Displacement Measuring Systems and Devices Used in Material Testing Machines
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F1714 Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1717 Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
F1877 Practice for Characterization of Particles
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
F2423 Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
1
This test method 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 Dec. 1, 2012Dec. 1, 2016. Published February 2013December 2016. Originally approved in 2007. Last previous edition approved in 20072012
as F1587 – 07.F2624 – 12. DOI: 10.1520/F2624-12.10.1520/F2624-12R16.
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’sstandard’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 ----------------------
F2624 − 12 (2016)
3. Terminology
3.1 All terminology is consistent with the referenced standards, unless otherwise stated.
3.2 Definitions:
3.2.1 center of rotation (COR)—the poin
...