ASTM F2083-08

Standard Specification for Total Knee Prosthesis

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 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. 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 F 1672.
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. This includes primary and revision prostheses and also covers fixed and mobile bearing knee designs.
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.
1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; unicompartmental designs, which replace the articulating surfaces of only one condyle; 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.

General Information

• Status: Historical
• Publication Date: 30-Jun-2008
• 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

• Replaces: ASTM F2083-07 - Standard Specification for Total Knee Prosthesis
• Effective Date: 01-Jul-2008
• Replaced By: ASTM F2083-08e1 - Standard Specification for Total Knee Prosthesis
• Effective Date: 01-Jul-2008
• Referred By: ASTM F2777-23 - Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
• Effective Date: 01-Jul-2008
• Referred By: ASTM F2722-21 - Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
• Effective Date: 01-Jul-2008
• Referred By: ASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
• Effective Date: 01-Jul-2008
• Referred By: ASTM F3140-23 - Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
• Effective Date: 01-Jul-2008
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Jul-2008
• Referred By: ASTM F3495-23 - Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
• Effective Date: 01-Jul-2008
• Referred By: ASTM F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
• Effective Date: 01-Jul-2008
• Referred By: ASTM F1800-19e1 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• Effective Date: 01-Jul-2008

Standards Content (Sample)

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: F 2083 – 08
Standard Specification for
1
Total Knee Prosthesis
This standard is issued under the fixed designation F 2083; 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 F86 Practice for Surface Preparation and Marking of Me-
tallic Surgical Implants
1.1 This specification covers total knee replacement (TKR)
F90 Specification for Wrought Cobalt-20Chromium-
prostheses used to provide functioning articulation by employ-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
ing femoral and tibial components, allowing a minimum of
tions (UNS R30605)
110° of flexion to high flexion.Although a patellar component
F 136 Specification for Wrought Titanium-6Aluminum-
may be considered an integral part of a TKR, the detailed
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
description of this component is excluded here since it is
Implant Applications (UNS R56401)
provided in Specification F 1672.
F 138 Specification for Wrought 18Chromium-14Nickel-
1.2 Included within the scope of this specification are
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
replaceablecomponentsofmodulardesigns,forexample,tibial
Implants (UNS S31673)
articulating surfaces and all components labeled for, or capable
F 451 Specification for Acrylic Bone Cement
of, being used with cement, regardless of whether the same
F 562 Specification for Wrought 35Cobalt-35Nickel-
components can also be used without cement. This includes
20Chromium-10Molybdenum Alloy for Surgical Implant
primary and revision prostheses and also covers fixed and
Applications (UNS R30035)
mobile bearing knee designs.
F 563 Specification for Wrought Cobalt-20Nickel-
1.3 This specification is intended to provide basic descrip-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
tions of material and prosthesis geometry. Additionally, those
3
for Surgical Implant Applications (UNS R30563)
characteristics determined to be important to in vivo perfor-
F 648 Specification for Ultra-High-Molecular-Weight Poly-
mance of the prosthesis are defined.
ethylene Powder and Fabricated Form for Surgical Im-
1.4 Excluded from the scope are hemiarthroplasty devices
plants
that replace only the femoral or tibial surface, but not both;
F 732 Test Method forWearTesting of Polymeric Materials
unicompartmental designs, which replace the articulating sur-
Used in Total Joint Prostheses
faces of only one condyle; and patellofemoral prostheses.Also
F 745 Specification for 18Chromium-12.5Nickel-
excluded are devices designed for custom applications.
2.5Molybdenum Stainless Steel for Cast and Solution-
1.5 The values stated in SI units are to be regarded as
Annealed Surgical Implant Applications
standard. No other units of measurement are included in this
F 746 Test Method for Pitting or Crevice Corrosion of
standard.
Metallic Surgical Implant Materials
2. Referenced Documents
F 748 Practice for Selecting Generic Biological Test Meth-
2
ods for Materials and Devices
2.1 ASTM Standards:
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
F67 Specification for Unalloyed Titanium, for Surgical
Alloy Forgings for Surgical Implants (UNS R31537,
Implant Applications (UNS R50250, UNS R50400, UNS
R31538, R31539)
R50550, UNS R50700)
F 981 Practice for Assessment of Compatibility of Bioma-
F75 SpecificationforCobalt-28Chromium-6Molybdenum
terials for Surgical Implants with Respect to Effect of
Alloy Castings and Casting Alloy for Surgical Implants
Materials on Muscle and Bone
(UNS R30075)
F 983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
1
This specification is under the jurisdiction of ASTM Committee F04 on
F 1044 Test Method for Shear Testing of Calcium Phos-
Medical and Surgical Materials and Devices and is the direct responsibility of
phate Coatings and Metallic Coatings
Subcommittee F04.22 on Arthroplasty.
F 1108 Specification for Titanium-6Aluminum-4Vanadium
Current edition approved July 1, 2008. Published August 2008. Originally
approved in 2001. Last previous edition approved in 2007 as F 2083 – 07.
Alloy Castings for Surgical Implants (UNS R56406)
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
3
the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2083–08
F 1147 Test Method for Tension Testing of Calcium Phos- restrict unwanted
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2083–07 Designation: F 2083 – 08
Standard Specification for
1
Total Knee Prosthesis
This standard is issued under the fixed designation F 2083; 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 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. 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 F 1672.
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. This includes primary and revision prostheses and also covers fixed and mobile
bearing knee designs.
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.
1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both;
unicompartmental designs, which replace the articulating surfaces of only one condyle; 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F 67 SpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,UNS
R50700)
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F 86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F 451 Specification for Acrylic Bone Cement
F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F 563 SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5IronAlloyforSurgicalImplant
Applications (UNS R30563)
F 648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F 732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F 745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical
Implant Applications
F 746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
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 Aug.July 1, 2007.2008. Published September 2007.August 2008. Originally approved in 2001. Last previous edition approved in 20062007 as
F2083–06b.F 2083 – 07.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. 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 ----------------------
F2083–08
F 799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F 983 Practice for Permanent Marking of Orthopae
...