ASTM F1814-22
(Guide)Standard Guide for Evaluating Modular Hip and Knee Joint Components
Standard Guide for Evaluating Modular Hip and Knee Joint Components
SIGNIFICANCE AND USE
4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip and modular knee components.
4.2 Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs.
4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.
4.4 Tests that are checked in Table 1, Table 2, or Table 3 or indicated in this guide as a possible test to consider may not be applicable to every implant design.
SCOPE
1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.
1.4 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.
1.5 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.
General Information
- Status
- Published
- Publication Date
- 14-Jul-2022
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.22 - Arthroplasty
Relations
- Effective Date
- 01-Nov-2019
- Effective Date
- 01-Oct-2019
- Effective Date
- 01-Oct-2019
- Effective Date
- 01-Jul-2013
- Effective Date
- 01-Mar-2013
- Effective Date
- 01-Feb-2013
- Effective Date
- 01-Feb-2013
- Effective Date
- 15-Dec-2012
- Effective Date
- 01-Mar-2011
- Effective Date
- 01-Dec-2010
- Effective Date
- 15-Sep-2010
- Effective Date
- 01-Dec-2009
- Effective Date
- 15-Sep-2009
- Effective Date
- 01-Feb-2009
- Effective Date
- 15-Dec-2008
Overview
ASTM F1814-22: Standard Guide for Evaluating Modular Hip and Knee Joint Components provides a comprehensive framework for evaluating the safety and performance of modular hip and knee prosthetic implants. Developed by ASTM International, this guide aids implant developers and researchers in identifying appropriate tests and evaluations required for assessing device safety, especially considering the diverse designs in modular orthopedic devices. This standard is particularly valuable for guiding the evaluation process of modular connections utilized in total joint arthroplasty, including both hip and knee replacements.
Key Topics
Scope and Applicability
- Designed to assist developers in choosing relevant test procedures for modular joint replacement implants.
- Addresses issues specific to modularity, such as the potential for unintentional disassembly, fatigue, and corrosion.
- Does not prescribe all-inclusive test methods but provides a checklist for common areas of concern.
Types of Testing Recommended
- Assembly testing: Evaluates static assembly parameters, including axial engagement force and torsional requirements, to ensure adequate connection strength.
- Disassembly testing: Assesses the minimum force or torque required to prevent unintentional disassembly during in vivo use.
- Cyclic fatigue testing: Analyzes the effect of repeated loading, simulating real-world conditions, on the integrity and durability of modular connections.
- Sterilization effects: Considers how sterilization processes may impact the fatigue performance of modular connections.
- Corrosion and fretting: Addresses potential adverse effects caused by micromotion, material combinations, and environmental exposure.
Design Considerations
- Recognizes that the variety of modular implant designs necessitates a flexible, case-by-case approach to safety evaluation.
- Encourages developers to document all testing and justify chosen methodologies in relation to specific implant features.
Applications
ASTM F1814-22 is used by:
Orthopedic Device Manufacturers
- During the design and development of new modular hip and knee implants to ensure robust product validation.
- For documenting compliance with international regulatory and quality standards.
Testing Laboratories
- When selecting or developing test protocols to ensure repeatable, standardized safety evaluations of modular connections found in joint replacement devices.
Clinical Investigators and Researchers
- As a guideline for identifying critical risk areas such as disassembly, mechanical failure, corrosion, and material compatibility in modular joint prostheses.
Regulatory Bodies
- As a reference for auditing and approving pre-market submissions related to the safety of orthopedic implants.
Related Standards
ASTM F1814-22 is frequently used in conjunction with other key standards, including:
- ASTM F648: Ultra-high-molecular-weight polyethylene specifications for surgical implants.
- ASTM F897: Test method for measuring fretting corrosion of osteosynthesis plates and screws.
- ASTM F1800: Practice for cyclic fatigue testing of metal tibial tray components in knee replacements.
- ASTM F1820: Determining forces for disassembly of modular acetabular devices.
- ASTM F1875: Fretting corrosion testing of hip modular implant interfaces.
- ASTM F2009: Axial disassembly force of taper connections in modular prostheses.
- ASTM F2345: Fatigue strength of ceramic modular femoral heads.
- ASTM F2580: Evaluation of modular connection in proximally fixed femoral hip prosthesis.
- ASTM F2582: Dynamic impingement testing for hip components.
- ASTM F2723: Testing mobile bearing knee tibial baseplate/bearing resistance.
- ASTM F3090: Fatigue testing of acetabular devices for total hip replacement.
- ISO 7206 series: International standards for endurance, performance, and load-bearing aspects of hip joint prostheses.
Practical Value
The guide ensures more consistent, repeatable, and thorough evaluation of modular hip and knee implant safety, which is critical for device longevity, patient safety, and regulatory approval. By addressing key risks in modular connections - such as fatigue failure, unintentional disassembly, corrosion, and wear - ASTM F1814-22 supports the advancement of safer, longer-lasting orthopedic implants. Its application facilitates transparency, regulatory compliance, and ultimately, improved patient outcomes in joint replacement surgeries.
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Frequently Asked Questions
ASTM F1814-22 is a guide published by ASTM International. Its full title is "Standard Guide for Evaluating Modular Hip and Knee Joint Components". This standard covers: SIGNIFICANCE AND USE 4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip and modular knee components. 4.2 Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs. 4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any. 4.4 Tests that are checked in Table 1, Table 2, or Table 3 or indicated in this guide as a possible test to consider may not be applicable to every implant design. SCOPE 1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety. 1.2 This guide does not attempt to define all test methods associated with modular device evaluation. 1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads. 1.4 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. 1.5 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.
SIGNIFICANCE AND USE 4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip and modular knee components. 4.2 Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs. 4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any. 4.4 Tests that are checked in Table 1, Table 2, or Table 3 or indicated in this guide as a possible test to consider may not be applicable to every implant design. SCOPE 1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety. 1.2 This guide does not attempt to define all test methods associated with modular device evaluation. 1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads. 1.4 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. 1.5 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.
ASTM F1814-22 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F1814-22 has the following relationships with other standards: It is inter standard links to ASTM F897-19, ASTM F1800-19e1, ASTM F1800-19, ASTM F648-13, ASTM F897-02(2013), ASTM F2580-13, ASTM F2723-13, ASTM F1800-12, ASTM F2009-00(2011), ASTM F648-10a, ASTM F648-10, ASTM F1875-98(2009), ASTM F2580-09, ASTM F1820-97(2009), ASTM F2345-03(2008). Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F1814-22 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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: F1814 − 22
Standard Guide for
Evaluating Modular Hip and Knee Joint Components
This standard is issued under the fixed designation F1814; 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 F1875 Practice for Fretting Corrosion Testing of Modular
Implant Interfaces: Hip Femoral Head-Bore and Cone
1.1 This guide covers a procedure to assist the developer of
Taper Interface
a modular joint replacement implant in the choice of appropri-
F2009 Test Method for Determining the Axial Disassembly
ate tests and evaluations to determine device safety.
Force of Taper Connections of Modular Prostheses
1.2 This guide does not attempt to define all test methods
F2345 Test Methods for Determination of Cyclic Fatigue
associated with modular device evaluation.
Strength of Ceramic Modular Femoral Heads
F2580 Practice for Evaluation of Modular Connection of
1.3 The disassembly testing in this guide does not cover
intentional intraoperative disassembly but is meant only to Proximally Fixed Femoral Hip Prosthesis
F2582 Test Method for Dynamic Impingement Between
suggest testing necessary to determine inadvertent disassembly
loads. Femoral and Acetabular Hip Components
F2723 Test Method for Evaluating Mobile Bearing Knee
1.4 This standard does not purport to address all of the
Tibial Baseplate/Bearing Resistance to Dynamic Disasso-
safety concerns, if any, associated with its use. It is the
ciation
responsibility of the user of this standard to establish appro-
F3090 Test Method for Fatigue Testing of Acetabular De-
priate safety, health, and environmental practices and deter-
vices for Total Hip Replacement
mine the applicability of regulatory limitations prior to use.
2.2 ISO Standards:
1.5 This international standard was developed in accor-
ISO 7206-4 Implants for surgery – Partial and total hip joint
dance with internationally recognized principles on standard-
prostheses – Part 4: Determination of endurance proper-
ization established in the Decision on Principles for the
ties and performance of stemmed femoral components
Development of International Standards, Guides and Recom-
ISO 7206-6 Implants for surgery – Partial and total hip joint
mendations issued by the World Trade Organization Technical
prostheses – Part 6: Endurance properties testing and
Barriers to Trade (TBT) Committee.
performance requirements of neck region of stemmed
femoral components
2. Referenced Documents
ISO 7206-10 Implants for surgery – Partial and total hip-
2.1 ASTM Standards:
joint prostheses – Part 10: Determination of resistance to
F648 Specification for Ultra-High-Molecular-Weight Poly-
static load of modular femoral heads
ethylene Powder and Fabricated Form for Surgical Im-
ISO 7206-13 Implants for surgery – Partial and total hip
plants
joint prostheses – Part 13: Determination of resistance to
F897 Test Method for Measuring Fretting Corrosion of
torque of head fixation of stemmed femoral components
Osteosynthesis Plates and Screws
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial
3. Terminology
Tray Components of Total Knee Joint Replacements
3.1 Definitions of Terms Specific to This Standard:
F1820 Test Method for Determining the Forces for Disas-
3.1.1 modular femoral hip implant—any device that is
sembly of Modular Acetabular Devices
constructed of two or more mating parts intended for implan-
tation into the femur for the purpose of replacing the femoral
hip joint.
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.1.1 bolts/screws—a fastener used to secure modular
F04.22 on Arthroplasty.
pieces of a femoral or tibial component.
Current edition approved July 15, 2022. Published August 2022. Originally
approved in 1997. Last previous edition approved in 2015 as F1814 – 15. DOI:
3.1.1.2 collar—medial platform located immediately distal
10.1520/F1814-22.
to the femoral neck.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1814 − 22
3.1.1.3 distal hip bullets/sleeves—modular accessories for 5. Testing
increasing the length or distal diameter of the femoral compo-
5.1 Assembly—Static assembly parameters should be evalu-
nent.
ated to determine the minimum required loads (axial or
3.1.1.4 femoral head—a modular bearing, spherical in
torsional) that ensure adequate assembly strengths.This testing
shape, that mates with the femoral component.
can be performed in conjunction with 5.2, Disassembly,to
ascertain how various assembly loads affect disassembly.
3.1.1.5 neck extension—an intermediate modular coupling
5.1.1 Axial Engagement Force—The force required to con-
between the femoral component and the femoral head.Attach-
nect the components (for example, to engage a tapered con-
ments (for example, threads and tapers) can vary.
nection). Consider the following:
3.1.1.6 proximal hip sleeves/pads—modular accessories for
5.1.1.1 The procedure for applying the engagement force
varying the geometry of the femoral component in the meta-
(clinical relevance);
physeal area.
5.1.1.2 The environment in which the components are
3.1.2 modular knee implant—any device that is constructed
connected (contamination); and
of two or more mating parts intended for implantation into the
5.1.1.3 Test Method F2009, ISO 7206-10.
femur or tibia for the purpose of replacing the knee joint.
5.1.2 Torsional—The torque required to connect the com-
3.1.2.1 knee sleeve—a modular addition to a total knee
ponents (for example, bolt or screw). This may only be
replacement that serves the function of filling voids left by
applicable for threaded connections. Consider the following:
deficient or absent bone stock. Commonly a sleeve circumfer-
5.1.2.1 Theprocedureforapplyingthetorsionalforce(clini-
entiallysurroundsthekneereplacementcomponentwithwhich
cal relevance).
it mates.
5.2 Disassembly—Static disassembly parameters should be
3.1.2.2 knee stem extension—modular extension to either a
evaluated to assess minimum design requirements for prevent-
knee-femoral or knee-tibial component which extends into the
ing unintentional in vivo disassembly.
medullary canal. A stem extension may be attached to the
5.2.1 Axial—The axial force required to disassemble mating
femoral or tibial component by a variety of means including a
components (for example, the force required to disassociate a
taper, screw, etc.
tapered junction, femoral head/bipolar head pull-out, femoral
3.1.2.3 knee wedge—a modular addition to a total knee
head/dual mobility head pull-out, or femoral head/constrained
replacement that serves the function of filling voids left by
liner pull-out, acetabular liner/acetabular shell push-out). Con-
deficient or absent bone stock. Commonly a wedge does not
sider the following:
circumferentially surround the knee replacement component
5.2.1.1 Test Method F1820 includes a push-out test method
with which it mates.
for an acetabular liner component connection to an acetabular
3.1.2.4 metal-backed patella—a modular patellar replace-
shell. Test Method F1820 does not specify applicability to
ment consisting of an articular piece which is secured to a
bipolar head, dual mobility head, and constrained liner con-
metal backing by means of a locking mechanism.
nection to a femoral head, but certain elements may be
applicable.
3.1.2.5 metal tibial tray—a metal component secured to the
5.2.1.2 Test Method F2009, ISO 7206-10, Test Method
proximal tibia which provides mechanical support to and
F1820.
couples directly with the modular tibial inserts.
5.2.2 Shear—The shear force required to disassemble mat-
3.1.2.6 tibial insert—a modular bearing member of a tibial
ing components (for example, the force required to shear a
component, usually made in accordance with Specification
wedge from a tray).
F648, that is secured to a knee tibial tray by means of a locking
5.2.3 Bending (or lever-off for bipolar head, dual mobility
mechanism.
head, and constrained liner connection to a femoral head; and
lever-out/offset pull-out for acetabular liner component con-
4. Significance and Use
nection to an acetabular shell)—The possibility of static
4.1 The tests suggested within this guide cover many
disassociation under combined loading. Consider the follow-
different, but not all possible, areas of research and concern
ing:
with regard to modular hip and modular knee components.
5.2.3.1 TestMethodF1820includeslever-
...
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: F1814 − 15 F1814 − 22
Standard Guide for
Evaluating Modular Hip and Knee Joint Components
This standard is issued under the fixed designation F1814; 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 guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests
and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 This The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest
testing necessary to determine inadvertent disassembly loads.
1.4 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.
1.5 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. Referenced Documents
2.1 ASTM Standards:
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F897 Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
F1820 Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
F1875 Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
F2009 Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
F2345 Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
F2580 Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
F2582 Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
F2723 Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
F3090 Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
2.2 ISO Standard:Standards:
ISO 7206-4:2010 7206-4 Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance
properties and performance of stemmed femoral components
This guide 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 Oct. 15, 2015July 15, 2022. Published December 2015August 2022. Originally approved in 1997. Last previous edition approved in 20092015
as F1814 – 97aF1814 – 15.(2009). DOI: 10.1520/F1814-15.10.1520/F1814-22.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1814 − 22
ISO 7206-6:20137206-6 Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and
performance requirements of neck region of stemmed femoral components
ISO 7206-10 Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load
of modular femoral heads
ISO 7206-13 Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head
fixation of stemmed femoral components
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 modular femoral hip implant—any device that is constructed of two or more mating parts intended for implantation into the
femur for the purpose of replacing the femoral hip joint.
3.1.1.1 bolts/screws—a fastener used to secure modular pieces of a femoral or tibial component.
3.1.1.2 collar—medial platform located immediately distal to the femoral neck.
3.1.1.3 bullets/distal sleeves—distal hip bullets/sleeves—modular accessories for increasing the length or distal diameter of the
femoral component.
3.1.1.3 collar—medial platform located immediately distal to the femoral neck.
3.1.1.4 femoral head—a modular bearing, spherical in shape, that mates with the femoral component.
3.1.1.5 neck extension—an intermediate modular couplecoupling between the femoral component and the femoral head.
Attachments (for example, threads and tapers) can vary.
3.1.1.6 proximal hip sleeves/pads—modular accessories for varying the geometry of the femoral component in the metaphyseal
area.
3.1.2 modular knee implant—any device that is constructed of two or more mating parts intended for implantation into the femur
or tibia for the purpose of replacing the knee joint.
3.1.2.1 knee sleeve—a modular addition to a total knee replacement that serves the function of filling voids left by deficient or
absent bone stock. Commonly a sleeve circumferentially surrounds the knee replacement component with which it mates.
3.1.2.2 knee stem extension—modular extension to either a knee-femoral or knee-tibial component which extends into the
medullary canal. A stem extension may be attached to the femoral or tibial component by a variety of means including a taper,
screw, etc.
3.1.2.3 knee wedge—a modular addition to a total knee replacement that serves the function of filling voids left by deficient or
absent bone stock. Commonly a wedge does not circumferentially surround the knee replacement component with which it mates.
3.1.2.4 metal-backed patella—a modular patellar replacement consisting of an articular piece which is secured to a metal
backing by means of a locking mechanism.
3.1.2.5 metal tibial tray—a metal component secured to the proximal tibia which provides mechanical support to and couples
directly with the modular tibial inserts.
3.1.2.3 stem extension or sleeve—modular extension to either a knee-femoral or knee-tibial component which extends into the
medullary canal. A stem extension may be attached to the femoral or tibial component by a variety of means including a taper,
screw, etc.
3.1.2.6 tibial insert—a modular bearing member of a tibial component, usually made in accordance with Specification F648,
that is secured to a knee tibial tray by means of a locking mechanism.
3.1.2.5 wedge—a modular addition to a total knee replacement that serves the function of filling voids left by deficient or absent
bone stock.
4. Significance and Use
4.1 The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to
modular hip stems and modular knee components.
4.2 Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with
regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the
responsibility of the investigator to address all safety concerns that are inherent to individual modular designs.
4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.
F1814 − 22
4.4 Tests that are checked in Table 1, Table 2, or Table 23 or indicated in this guide as a possible test to consider may not be
applicable to every implant design.
5. Testing
5.1 Assembly—Static assembly parameters should be evaluated to determine the minimum required loads (axial or torsional) that
ensure adequate assembly strengths. This testing can be performed in conjunction with 5.2, Disassembly, to ascertain how various
assembly loads affect disassembly.
5.1.1 Axial Engagement Force—The force required to connect the components (for example, to engage a tapered connection).
Consider the following:
5.1.1.1 The procedure for applying the engagement force (clinical relevance), andrelevance);
5.1.1.2 The environment in which the components are connected (contamination).(contamination); and
5.1.1.3 Test Method F2009, ISO 7206-10.
5.1.2 Torsional—The torque required to connect the components (for example, bolt or screw). This may only be applicable for
threaded connections. Consider the following:
5.1.2.1 The procedure for applying the torsional force (clinical relevance).
5.2 Disassembly—Static disassembly parameters should be evaluated to assess minimum design requirements for preventing
unintentional in vivo disassembly.
5.2.1 Axial—The axial force required to disassemble mating components (for example, the force required to disassociate a tapered
junction).junction, femoral head/bipolar head pull-out, femoral head/dual mobility head pull-out, or femoral head/constrained liner
pull-out, acetabular liner/acetabular shell push-out). Consider the following:
5.2.1.1 Test Method F1820 includes a push-out test method for an acetabular liner component connection to an acetabular shell.
Test Method F1820 does not specify applicability to bipolar head, dual mobility head, and constrained
...
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