ASTM F2777-23

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles.  
4.2 The loading and kinematics of bearing component designs in vivo will, in general, differ from the loading and kinematics defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to enable comparisons between the fatigue performance of different bearing component designs when tested under similar conditions.  
4.3 The test described is applicable to any bicompartmental knee design, including mobile bearing knees that have mechanisms in the tibial articulating component to constrain the posterior movement of the femoral component and a built-in retention mechanism to keep the articulating component on the tibial plate.
SCOPE
1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling.  
1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions.  
1.4 This test method applies to bearing components manufactured from UHMWPE.  
1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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.

General Information

• Status: Published
• Publication Date: 31-Aug-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Refers: ASTM F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
• Effective Date: 15-Jun-2020

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: F2777 − 23
Standard Test Method for
Evaluating Knee Bearing (Tibial Insert) Endurance and
1
Deformation Under High Flexion
This standard is issued under the fixed designation F2777; 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This standard specifies a test method for determining the
endurance properties and deformation, under specified labora-
2. Referenced Documents
tory conditions, of ultra high molecular weight polyethylene
2
2.1 ASTM Standards:
(UHMWPE) tibial bearing components used in bicompartmen-
F1223 Test Method for Determination of Total Knee Re-
tal or tricompartmental knee prosthesis designs.
placement Constraint
1.2 This test method is intended to simulate near posterior
F2003 Practice for Accelerated Aging of Ultra-High Mo-
edge loading similar to the type of loading that would occur
lecular Weight Polyethylene After Gamma Irradiation in
during high flexion motions such as squatting or kneeling.
Air
1.3 Although the methodology described attempts to iden-
F2083 Specification for Knee Replacement Prosthesis
tify physiological orientations and loading conditions, the 3
2.2 Other Standards:
interpretation of results is limited to an in vitro comparison
ISO 4965-1 Metallic Materials—Dynamic Force Calibration
between knee prosthesis designs and their ability to resist
for Uniaxial Fatigue Testing—Part 1: Testing System
deformation and fracture under stated test conditions.
ISO 5833 Implants for Surgery—Acrylic Resin Cements
1.4 This test method applies to bearing components manu-
ISO 14243-1 Implants for Surgery—Wear of Total Knee-
factured from UHMWPE.
joint Prostheses—Part 1: Loading and Displacement Pa-
rameters for Wear-testing Machines with Load Control
1.5 This test method could be adapted to address unicom-
and Corresponding Environmental Conditions for Test
partmental total knee replacement (TKR) systems, provided
ISO 14243-3 Implants for Surgery—Wear of Total Knee-
that the designs of the unicompartmental systems have suffi-
joint Prostheses—Part 3: Loading and Displacement Pa-
cient constraint to allow use of this test method. This test
rameters for Wear-testing Machines with Displacement
method does not include instructions for testing two unicom-
Control and Corresponding Environmental Conditions for
partmental knees as a bicompartmental system.
Test
1.6 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3. Terminology
standard.
3.1 Definitions:
1.7 This standard does not purport to address all of the
3.1.1 anatomic (mechanical) axis of the femur—the line
safety concerns, if any, associated with its use. It is the
between the center of the femoral head and the center of the
responsibility of the user of this standard to establish appro-
femoral knee.
priate safety, health, and environmental practices and deter-
3.1.2 bearing centerline—the line running anteroposterior
mine the applicability of regulatory limitations prior to use.
that is the mirror line of the tibial bearing (tibial insert). For
1.8 This international standard was developed in accor-
asymmetric tibial bearing designs, the appropriate tibial bear-
dance with internationally recognized principles on standard-
ing centerline shall be determined and reported along with the
ization established in the Decision on Principles for the
rationale for the location.
Development of International Standards, Guides and Recom-
1 2
This test method is under the jurisdiction of ASTM Committee F04 on Medical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
and Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.22 on Arthroplasty. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2023. Published September 2023. Originally the ASTM website.
3
approved in 2010. Last previous edition approved in 2016 as F2777 – 16. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2777-23. 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
1

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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: F2777 − 16 F2777 − 23
Standard Test Method for
Evaluating Knee Bearing (Tibial Insert) Endurance and
1
Deformation Under High Flexion
This standard is issued under the fixed designation F2777; 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 standard specifies a test method for determining the endurance properties and deformation, under specified laboratory
conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or
tricompartmental knee prosthesis designs.
1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high
flexion motions such as squatting or kneeling.
1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation
of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture
under stated test conditions.
1.4 This test method applies to bearing components manufactured from UHMWPE.
1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the
designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not
include instructions for testing two unicompartmental knees as a bicompartmental system.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 and health practices and determine the applicability of regulatory
limitations prior to use.
1.7 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
F04.22 on Arthroplasty.
Current edition approved July 1, 2016Sept. 1, 2023. Published August 2016September 2023. Originally approved in 2010. Last previous edition approved in 20102016
as F2777F2777 – 16.–10. DOI: 10.1520/F2777-16.10.1520/F2777-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2777 − 23
2. Referenced Documents
2
2.1 ASTM Standards:
F1223 Test Method for Determination of Total Knee Replacement Constraint
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
F2083 Specification for Knee Replacement Prosthesis
3
2.2 Other Standards:
ISO 4965–14965-1 Metallic materials—DynamicMaterials—Dynamic Force Calibration for uniaxial fatigue testing —Part 1:
Testing systemUniaxial Fatigue Testing—Part 1: Testing System
ISO 5833 Implants for Surgery—Acrylic Resin Cements
ISO 14243-1 Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 1: Loading and Displacement Parameters for
Wear-testing Machines with Load Control and Corresponding Environmental Conditions for Test
ISO 14243-3 Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement Parameters for
Wear-testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
3. Terminology
3.1 Definitions:
3.1.1 anatomic (mechanical) axis of the femur—the line between the center of the femoral head and the center of the femoral knee.
3.1.2 bearing centerline—the line running anteroposterior that is the mirror line of the femoral articulating
...