ASTM F2083-21
(Specification)Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
ABSTRACT
This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum of 110° of flexion to high flexion. Replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for or capable of being used with cement, regardless of whether the same components can also be used without cement are described. Primary and revision prostheses and also covers fixed and mobile bearing knee designs are discussed. Basic descriptions of material and prosthesis geometry are provided. Additionally, those characteristics determined to be important to in vivo performance of the prosthesis are defined. The prostheses are classified into three kinds according to degree of constraint. The first kind is considered constrained which prevents dislocation of the prosthesis in more than one anatomic plane and consists of either a single, flexible, across-the-joint component or more than one component linked together or affined. The second one is a semiconstrained joint prosthesis which limits translation or rotation, or both, of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no across-the-joint linkages. The third kind is a nonconstrained joint prosthesis which minimally restricts prosthesis movement in one or more planes. Its components have no across-the-joint linkages. The choice of materials is understood to be a necessary but not sufficient assurance of function of the device made from them. All devices shall be fabricated from materials with adequate mechanical strength and durability, corrosion resistance, and biocompatibility.
SCOPE
1.1 This specification is intended to cover all the widely used generic types of knee replacement prostheses used to provide functioning articulation. This includes total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses of both fixed and mobile bearing varieties, and for primary or revision surgeries. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F1672.
1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for, or capable of, being used with cement, regardless of whether the same components can also be used without cement.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to in-vivo performance of the prosthesis are defined. However, compliance with this specification does not itself define a device that will provide adequate clinical performance.
1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; and patellofemoral prostheses. Also excluded are devices designed for custom applications.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.
1.7 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.
WITHDRAWN RATIONALE
This specification was intended to cover all the widely used generic types of knee replacement prosthes...
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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:F2083 −21
Standard Specification for
1
Knee Replacement Prosthesis
This standard is issued under the fixed designation F2083; 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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This specification is intended to cover all the widely
Barriers to Trade (TBT) Committee.
used generic types of knee replacement prostheses used to
provide functioning articulation. This includes total knee
2. Referenced Documents
replacement (TKR) and unicondylar knee replacement (UKR)
2
2.1 ASTM Standards:
prostheses of both fixed and mobile bearing varieties, and for
E739 PracticeforStatisticalAnalysisofLinearorLinearized
primary or revision surgeries. Although a patellar component
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
may be considered an integral part of a TKR, the detailed
F67 Specification for Unalloyed Titanium, for Surgical Im-
description of this component is excluded here since it is
plant Applications (UNS R50250, UNS R50400, UNS
provided in Specification F1672.
R50550, UNS R50700)
1.2 Included within the scope of this specification are
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
replaceablecomponentsofmodulardesigns,forexample,tibial
Alloy Castings and Casting Alloy for Surgical Implants
articulating surfaces and all components labeled for, or capable
(UNS R30075)
of, being used with cement, regardless of whether the same
F86 Practice for Surface Preparation and Marking of Metal-
components can also be used without cement.
lic Surgical Implants
1.3 This specification is intended to provide basic descrip-
F90 Specification for Wrought Cobalt-20Chromium-
tions of material and prosthesis geometry. Additionally, those
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
characteristics determined to be important to in-vivo perfor-
tions (UNS R30605)
manceoftheprosthesisaredefined.However,compliancewith
F136 Specification for Wrought Titanium-6Aluminum-
this specification does not itself define a device that will
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
provide adequate clinical performance.
Implant Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-
1.4 Excluded from the scope are hemiarthroplasty devices
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
thatreplaceonlythefemoralortibialsurface,butnotboth;and
Implants (UNS S31673)
patellofemoral prostheses.Also excluded are devices designed
F451 Specification for Acrylic Bone Cement
for custom applications.
F561 Practice for Retrieval and Analysis of Medical
1.5 The values stated in SI units are to be regarded as
Devices, and Associated Tissues and Fluids
standard. No other units of measurement are included in this
F562 Specification for Wrought 35Cobalt-35Nickel-
standard.
20Chromium-10Molybdenum Alloy for Surgical Implant
1.6 This standard does not purport to address all of the
Applications (UNS R30035)
safety concerns, if any, associated with its use. It is the
F648 Specification for Ultra-High-Molecular-Weight Poly-
responsibility of the user of this standard to establish appro-
ethylene Powder and Fabricated Form for Surgical Im-
priate safety, health, and environmental practices and deter-
plants
mine the applicability of regulatory limitations prior to use.
F732 Test Method for Wear Testing of Polymeric Materials
1.7 This international standard was developed in accor-
Used in Total Joint Prostheses
dance with internationally recognized principles on standard-
F746 Test Method for Pitting or Crevice Corrosion of
ization established in the Decision on Principles for the
Metallic Surgical Implant Materials
F748 PracticeforSelectingGenericBiologicalTestMethods
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Jan. 1, 2021. Published February 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2001. Last previous edition approved in 2012 as F2083 – 12. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2083-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C70
...
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: F2083 − 12 F2083 − 21
Standard Specification for
1
Knee Replacement Prosthesis
This standard is issued under the fixed designation F2083; 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 specification is intended to cover all the widely used generic types of knee replacement prostheses used to provide
functioning articulation. This includes total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses of both
fixed and mobile bearing varieties, and for primary or revision surgeries. Although a patellar component may be considered an
integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F1672.
1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating
surfaces and all components labeled for, or capable of, being used with cement, regardless of whether the same components can
also be used without cement.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those
characteristics determined to be important to in vivoin-vivo performance of the prosthesis are defined. However, compliance with
this specification does not itself define a device that will provide adequate clinical performance.
1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; and
patellofemoral prostheses. Also excluded are devices designed for custom applications.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.
1.7 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
2.1 ASTM Standards:
E739 Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
1
This specification 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 Nov. 1, 2012Jan. 1, 2021. Published April 2013February 2021. Originally approved in 2001. Last previous edition approved in 20112012 as
F2083 – 11.F2083 – 12. DOI: 10.1520/F2083-12.10.1520/F2083-21.
2
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2083 − 21
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F451 Specification for Acrylic Bone Cement
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specificatio
...
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: F2083 − 21
Standard Specification for
1
Knee Replacement Prosthesis
This standard is issued under the fixed designation F2083; 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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This specification is intended to cover all the widely
Barriers to Trade (TBT) Committee.
used generic types of knee replacement prostheses used to
provide functioning articulation. This includes total knee
2. Referenced Documents
replacement (TKR) and unicondylar knee replacement (UKR)
2
2.1 ASTM Standards:
prostheses of both fixed and mobile bearing varieties, and for
E739 Practice for Statistical Analysis of Linear or Linearized
primary or revision surgeries. Although a patellar component
Stress-Life (S-N) and Strain-Life (ε-N) Fatigue Data
may be considered an integral part of a TKR, the detailed
F67 Specification for Unalloyed Titanium, for Surgical Im-
description of this component is excluded here since it is
plant Applications (UNS R50250, UNS R50400, UNS
provided in Specification F1672.
R50550, UNS R50700)
1.2 Included within the scope of this specification are
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
replaceable components of modular designs, for example, tibial
Alloy Castings and Casting Alloy for Surgical Implants
articulating surfaces and all components labeled for, or capable
(UNS R30075)
of, being used with cement, regardless of whether the same
F86 Practice for Surface Preparation and Marking of Metal-
components can also be used without cement.
lic Surgical Implants
1.3 This specification is intended to provide basic descrip-
F90 Specification for Wrought Cobalt-20Chromium-
tions of material and prosthesis geometry. Additionally, those
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
characteristics determined to be important to in-vivo perfor-
tions (UNS R30605)
mance of the prosthesis are defined. However, compliance with
F136 Specification for Wrought Titanium-6Aluminum-
this specification does not itself define a device that will
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
provide adequate clinical performance.
Implant Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-
1.4 Excluded from the scope are hemiarthroplasty devices
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
that replace only the femoral or tibial surface, but not both; and
Implants (UNS S31673)
patellofemoral prostheses. Also excluded are devices designed
F451 Specification for Acrylic Bone Cement
for custom applications.
F561 Practice for Retrieval and Analysis of Medical
1.5 The values stated in SI units are to be regarded as
Devices, and Associated Tissues and Fluids
standard. No other units of measurement are included in this
F562 Specification for Wrought 35Cobalt-35Nickel-
standard.
20Chromium-10Molybdenum Alloy for Surgical Implant
1.6 This standard does not purport to address all of the
Applications (UNS R30035)
safety concerns, if any, associated with its use. It is the
F648 Specification for Ultra-High-Molecular-Weight Poly-
responsibility of the user of this standard to establish appro-
ethylene Powder and Fabricated Form for Surgical Im-
priate safety, health, and environmental practices and deter-
plants
mine the applicability of regulatory limitations prior to use.
F732 Test Method for Wear Testing of Polymeric Materials
1.7 This international standard was developed in accor-
Used in Total Joint Prostheses
dance with internationally recognized principles on standard-
F746 Test Method for Pitting or Crevice Corrosion of
ization established in the Decision on Principles for the
Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Jan. 1, 2021. Published February 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2001. Last previous edition approved in 2012 as F2083 – 12. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2083-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ------
...
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