ASTM F2723-21
(Test Method)Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
SIGNIFICANCE AND USE
3.1 This test method includes the use of static and fatigue shear and bending force conditions to evaluate the bearing retention mechanism of a mobile bearing knee design and its ability to prevent disassociation.
3.2 In general, disassociation does not occur during activities where the contact locations are within the boundaries of the bearing surfaces. Disassociation is most likely to occur with forces at the edges of the bearing component or with large AP shear forces on a posterior stabilized knee tibial component post. Extreme bearing rotation, bone/bearing impingement, severe varus or valgus moments, high flexion, or any combination of these can increase the likelihood of disassociation.
3.3 The test method described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism.
SCOPE
1.1 This test method describes a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing disassociation under repeated forces.
1.2 The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism.
1.3 Although the methodology described does not replicate all physiological force conditions, it is a means of in-vitro comparison of mobile bearing knee designs and the strength of the bearing retention mechanism between the tibial baseplate and bearing components under the stated test conditions.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 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: F2723 − 21
Standard Test Method for
Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing
1
Resistance to Dynamic Disassociation
This standard is issued under the fixed designation F2723; 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 2.1.3 inferior articulating interfaces—any interface in
which relative motion occurs between the underside of the
1.1 This test method describes a laboratory method for
mobile bearing component and the tibial tray.
evaluating the potential for mobile bearing knee tibial
baseplate/bearing disassociation under repeated forces. 2.1.4 limiting position—the position of the femoral compo-
nent relative to the bearing at which the shear force is at a
1.2 The test described is applicable to any bicompartmental
maximum with anterior-posterior (AP) movement of the femo-
mobile bearing knee with a bearing retention mechanism. With
ral component on the bearing.
modification, the test can be applied to a unicompartmental
2.1.5 mobile bearing—the component between fixed femo-
mobile bearing knee with a bearing retention mechanism.
ral and tibial knee components with an articulating surface on
1.3 Although the methodology described does not replicate
both the inferior and superior sides.
all physiological force conditions, it is a means of in-vitro
2.1.6 mobile bearing knee system—a knee prosthesis
comparison of mobile bearing knee designs and the strength of
system, comprising a tibial component, a mobile bearing
the bearing retention mechanism between the tibial baseplate
component that can rotate or rotate and translate relative to the
and bearing components under the stated test conditions.
tibial component, and a femoral component.
1.4 The values stated in SI units are to be regarded as
2.1.7 superior articulating interfaces—any interface in
standard. No other units of measurement are included in this
whichrelativemotionoccursbetweenthetopsideofthemobile
standard.
bearing component and the femoral bearing component.
1.5 This standard does not purport to address all of the
2.1.8 tibial baseplate/bearing disassociation—
safety concerns, if any, associated with its use. It is the
unrecoverable physical separation of the bearing and tibial
responsibility of the user of this standard to establish appro-
baseplate components as a result of bearing distraction or
priate safety, health, and environmental practices and deter-
tilting.
mine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accor-
2.1.9 two-axis orthogonal load frame—a test machine ca-
dance with internationally recognized principles on standard-
pable of applying forces and displacements that act at 90° to
ization established in the Decision on Principles for the
each other.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
3. Significance and Use
Barriers to Trade (TBT) Committee.
3.1 This test method includes the use of static and fatigue
shear and bending force conditions to evaluate the bearing
2. Terminology
retention mechanism of a mobile bearing knee design and its
2.1 Definitions:
ability to prevent disassociation.
2.1.1 bearing axis—the line connecting the lowest points on
3.2 In general, disassociation does not occur during activi-
both the lateral and medial condyles of the superior surface of
tieswherethecontactlocationsarewithintheboundariesofthe
the mobile bearing.
bearing surfaces. Disassociation is most likely to occur with
2.1.2 bearing retention mechanism—mechanical means pre-
forces at the edges of the bearing component or with large AP
venting tibial baseplate/bearing disassociation.
shear forces on a posterior stabilized knee tibial component
post. Extreme bearing rotation, bone/bearing impingement,
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
severe varus or valgus moments, high flexion, or any combi-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty. nation of these can increase the likelihood of disassociation.
Current edition approved March 1, 2021. Published March 2021. Originally
3.3 The test method described is applicable to any bicom-
approved in 2008. Last previous version approved in 2013 as F2723 – 13a. DOI:
10.1520/F2723-21. partmental mobile bearing knee with a bearing retention
Copyright © ASTM Internat
...
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: F2723 − 13a F2723 − 21
Standard Test Method for
Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing
1
Resistance to Dynamic Disassociation
This standard is issued under the fixed designation F2723; 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 a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing
disassociation under repeated forces.
1.2 The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With
modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism.
1.3 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitroin-vitro
comparison of mobile bearing knee designs and the strength of the bearing retention mechanism between the tibial baseplate and
bearing components under the stated test conditions.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 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.
2. Terminology
2.1 Definitions:
2.1.1 bearing axis—the line connecting the lowest points on both the lateral and medial condyles of the superior surface of the
mobile bearing.
2.1.2 bearing retention mechanism—mechanical means preventing tibial baseplate/bearing disassociation.
2.1.3 inferior articulating interfaces—any interface in which relative motion occurs between the underside of the mobile bearing
component and the tibial tray.
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
F04.22 on Arthroplasty.
Current edition approved July 15, 2013March 1, 2021. Published August 2013March 2021. Originally approved in 2008. Last previous version approved in 2013 as
F2723 – 13.F2723 – 13a. DOI: 10.1520/F2723-13A.10.1520/F2723-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2723 − 21
2.1.4 limiting position—the position of the femoral component relative to the bearing at which the shear force is at a maximum
with anterior-posterior (AP) movement of the femoral component on the bearing.
2.1.5 mobile bearing—the component between fixed femoral and tibial knee components with an articulating surface on both the
inferior and superior sides.
2.1.6 mobile bearing knee system—a knee prosthesis system, comprised of comprising a tibial component, a mobile bearing
component that can rotate or rotate and translate relative to the tibial component, and a femoral component.
2.1.7 superior articulating interfaces—any interface in which relative motion occurs between the topside of the mobile bearing
component and the femoral bearing component.
2.1.8 tibial baseplate/bearing disassociation—unrecoverable physical separation of the bearing and tibial baseplate components
as a result of bearing distraction or tilting.
2.1.9 2-axistwo-axis orthogonal load frame—a test machine capable of applying forces and displacements that act at 90° to each
other.
3. Significance and Use
3.1 This test method includes the use of static and fatigue shear and bending force conditions to evaluate the bearing retention
mechanism of a mobile bearing knee design and its ability to prevent disassociation.
3.2 In general, disassociation does not occur during activities where the contact locations are within the boundaries of the bearing
surfaces. Disassociation is most likely to occur with forces at the edges of the bear
...
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