ASTM F2267-22
(Test Method)Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
SIGNIFICANCE AND USE
5.1 Intervertebral body fusion devices are generally simple geometric-shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.
5.2 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.
5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.
5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.
1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2267 − 22
Standard Test Method for
Measuring Load-Induced Subsidence of Intervertebral Body
1
Fusion Device Under Static Axial Compression
This standard is issued under the fixed designation F2267; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This test method specifies the materials and methods for
mendations issued by the World Trade Organization Technical
the axial compressive subsidence testing of non-biologic in-
Barriers to Trade (TBT) Committee.
tervertebral body fusion devices, spinal implants designed to
promote arthrodesis at a given spinal motion segment.
2. Referenced Documents
1.2 This test method is intended to provide a basis for the
2
2.1 ASTM Standards:
mechanical comparison among past, present, and future non-
E4 Practices for Force Calibration and Verification of Test-
biologic intervertebral body fusion devices.This test method is
ing Machines
intended to enable the user to mechanically compare interver-
E177 Practice for Use of the Terms Precision and Bias in
tebral body fusion devices and does not purport to provide
ASTM Test Methods
performance standards for intervertebral body fusion devices.
E691 Practice for Conducting an Interlaboratory Study to
1.3 This test method describes a static test method by
Determine the Precision of a Test Method
specifying a load type and a specific method of applying this
F1582 Terminology Relating to Spinal Implants
load. This test method is designed to allow for the comparative
F1839 Specification for Rigid Polyurethane Foam for Use as
evaluation of intervertebral body fusion devices.
a Standard Material for Testing Orthopaedic Devices and
Instruments
1.4 Guidelines are established for measuring test block
F2077 Test Methods for Intervertebral Body Fusion Devices
deformation and determining the subsidence of intervertebral
body fusion devices.
3. Terminology
1.5 Since some intervertebral body fusion devices require
3.1 Allsubsidencetestingterminologyisconsistentwiththe
the use of additional implants for stabilization, the testing of
referenced standards above, unless otherwise stated.
these types of implants may not be in accordance with the
manufacturer’s recommended usage.
3.2 Definitions:
3.2.1 coordinate system/axes—three orthogonal axes are
1.6 Units—The values stated in SI units are to be regarded
defined by Terminology F1582 as seen in Fig. 4. The center of
as the standard with the exception of angular measurements,
the coordinate system is located at the geometric center of the
which may be reported in terms of either degrees or radians.
intervertebralbodyfusiondeviceassembly.The X-axisisalong
1.7 The use of this standard may involve the operation of
the longitudinal axis of the implant, with positive X in the
potentially hazardous equipment. This standard does not pur-
anterior direction, Y is lateral, and Z is cephalic.
port to address all of the safety concerns, if any, associated
3.2.2 ideal insertion location—the implant location with
with its use. It is the responsibility of the user of this standard
respect to the simulated inferior and superior vertebral bodies
to establish appropriate safety, health, and environmental
(polyurethane)dictatedbythetype,design,andmanufacturer’s
practices and determine the applicability of regulatory limita-
surgical installation instructions.
tions prior to use.
1.8 This international standard was developed in accor-
3.2.3 intended method of application—intervertebral body
dance with internationally recognized principles on standard-
fusion devices may contain different types of stabilizing
features such as threads, spikes, and knurled surfaces. Each
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2022. Published September 2022. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2018 as F2267 – 04 (2018). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F2267-22. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive,
...
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: F2267 − 04 (Reapproved 2018) F2267 − 22
Standard Test Method for
Measuring Load Induced Load-Induced Subsidence of
Intervertebral Body Fusion Device Under Static Axial
1
Compression
This standard is issued under the fixed designation F2267; 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 specifies the materials and methods for the axial compressive subsidence testing of non-biologic
intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic
intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body
fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test
method is designed to allow for the comparative evaluation of intervertebral body fusion devices.
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion
devices.
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types
of implants may not be in accordance with the manufacturer’s recommended usage.
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may
be reported in terms of either degrees or radians.
1.7 The use of this standard may involve the operation of potentially hazardous equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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 Feb. 1, 2018Sept. 1, 2022. Published April 2018September 2022. Originally approved in 2003. Last previous edition approved in 20112018 as
F2267 – 04 (2018).(2011). DOI: 10.1520/F2267-04R18.10.1520/F2267-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2267 − 22
2. Referenced Documents
2
2.1 ASTM Standards:
E4 Practices for Force Calibration and Verification of Testing Machines
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F1582 Terminology Relating to Spinal Implants
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and
Instruments
F2077 Test Methods for Intervertebral Body Fusion Devices
3. Terminology
3.1 All subsidence testing terminology is consistent with the referenced standards above, unless otherwise stated.
3.2 Definitions:
3.2.1 coordinate system/axes—three orthogonal axes are defined by Terminology F1582 as seen in Fig. 4. The center of the
coordinate system is located at the geometric center of the intervertebral body fusion device assembly. The X-axis is along the
longitudinal axis of the implant, with positive X in the anterior direction, Y is lateral, and Z is cephalic.
3.2.2 ideal insertion location—the implant location with respect to the simulated inferior and superior vertebral bodies
(polyurethane) dictated by the type, design, and manufacturer’s surgical installation instructions.
3.2.3 intended method of application—intervertebral body fusion dev
...
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: F2267 − 22
Standard Test Method for
Measuring Load-Induced Subsidence of Intervertebral Body
1
Fusion Device Under Static Axial Compression
This standard is issued under the fixed designation F2267; 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 ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This test method specifies the materials and methods for
mendations issued by the World Trade Organization Technical
the axial compressive subsidence testing of non-biologic in-
Barriers to Trade (TBT) Committee.
tervertebral body fusion devices, spinal implants designed to
promote arthrodesis at a given spinal motion segment.
2. Referenced Documents
1.2 This test method is intended to provide a basis for the
2
2.1 ASTM Standards:
mechanical comparison among past, present, and future non-
E4 Practices for Force Calibration and Verification of Test-
biologic intervertebral body fusion devices. This test method is
ing Machines
intended to enable the user to mechanically compare interver-
E177 Practice for Use of the Terms Precision and Bias in
tebral body fusion devices and does not purport to provide
ASTM Test Methods
performance standards for intervertebral body fusion devices.
E691 Practice for Conducting an Interlaboratory Study to
1.3 This test method describes a static test method by
Determine the Precision of a Test Method
specifying a load type and a specific method of applying this
F1582 Terminology Relating to Spinal Implants
load. This test method is designed to allow for the comparative
F1839 Specification for Rigid Polyurethane Foam for Use as
evaluation of intervertebral body fusion devices.
a Standard Material for Testing Orthopaedic Devices and
Instruments
1.4 Guidelines are established for measuring test block
F2077 Test Methods for Intervertebral Body Fusion Devices
deformation and determining the subsidence of intervertebral
body fusion devices.
3. Terminology
1.5 Since some intervertebral body fusion devices require
3.1 All subsidence testing terminology is consistent with the
the use of additional implants for stabilization, the testing of
referenced standards above, unless otherwise stated.
these types of implants may not be in accordance with the
manufacturer’s recommended usage.
3.2 Definitions:
3.2.1 coordinate system/axes—three orthogonal axes are
1.6 Units—The values stated in SI units are to be regarded
defined by Terminology F1582 as seen in Fig. 4. The center of
as the standard with the exception of angular measurements,
the coordinate system is located at the geometric center of the
which may be reported in terms of either degrees or radians.
intervertebral body fusion device assembly. The X-axis is along
1.7 The use of this standard may involve the operation of
the longitudinal axis of the implant, with positive X in the
potentially hazardous equipment. This standard does not pur-
anterior direction, Y is lateral, and Z is cephalic.
port to address all of the safety concerns, if any, associated
3.2.2 ideal insertion location—the implant location with
with its use. It is the responsibility of the user of this standard
respect to the simulated inferior and superior vertebral bodies
to establish appropriate safety, health, and environmental
(polyurethane) dictated by the type, design, and manufacturer’s
practices and determine the applicability of regulatory limita-
surgical installation instructions.
tions prior to use.
1.8 This international standard was developed in accor-
3.2.3 intended method of application—intervertebral body
dance with internationally recognized principles on standard-
fusion devices may contain different types of stabilizing
features such as threads, spikes, and knurled surfaces. Each
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
2
F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2022. Published September 2022. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2018 as F2267 – 04 (2018). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F2267-22. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2267
...
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