ASTM F2083-12

Standard Specification for Knee Replacement 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 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.

General Information

• Status: Historical
• Publication Date: 31-Oct-2012
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

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:F2083 −12
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 R50550, UNS R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
1.1 This specification is intended to cover all the widely
Alloy Castings and Casting Alloy for Surgical Implants
used generic types of knee replacement prostheses used to
(UNS R30075)
provide functioning articulation. This includes total knee
F86 Practice for Surface Preparation and Marking of Metal-
replacement (TKR) and unicondylar knee replacement (UKR)
lic Surgical Implants
prostheses of both fixed and mobile bearing varieties, and for
F90 Specification for Wrought Cobalt-20Chromium-
primary or revision surgeries. Although a patellar component
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
may be considered an integral part of a TKR, the detailed
tions (UNS R30605)
description of this component is excluded here since it is
F136 Specification for Wrought Titanium-6Aluminum-
provided in Specification F1672.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.2 Included within the scope of this specification are
Implant Applications (UNS R56401)
replaceablecomponentsofmodulardesigns,forexample,tibial
F138 Specification for Wrought 18Chromium-14Nickel-
articulating surfaces and all components labeled for, or capable
2.5Molybdenum Stainless Steel Bar andWire for Surgical
of, being used with cement, regardless of whether the same
Implants (UNS S31673)
components can also be used without cement.
F451 Specification for Acrylic Bone Cement
1.3 This specification is intended to provide basic descrip- F562 Specification for Wrought 35Cobalt-35Nickel-
20Chromium-10Molybdenum Alloy for Surgical Implant
tions of material and prosthesis geometry. Additionally, those
characteristics determined to be important to in vivo perfor- Applications (UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-
manceoftheprosthesisaredefined.However,compliancewith
this specification does not itself define a device that will 20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
for Surgical Implant Applications (UNS R30563) (With-
provide adequate clinical performance.
3
drawn 2005)
1.4 Excluded from the scope are hemiarthroplasty devices
F648 Specification for Ultra-High-Molecular-Weight Poly-
thatreplaceonlythefemoralortibialsurface,butnotboth;and
ethylene Powder and Fabricated Form for Surgical Im-
patellofemoral prostheses.Also excluded are devices designed
plants
for custom applications.
F732 Test Method for Wear Testing of Polymeric Materials
1.5 The values stated in SI units are to be regarded as
Used in Total Joint Prostheses
standard. No other units of measurement are included in this
F745 Specification for 18Chromium-12.5Nickel-
standard.
2.5Molybdenum Stainless Steel for Cast and Solution-
Annealed Surgical Implant Applications (Withdrawn
2. Referenced Documents
3
2012)
2
2.1 ASTM Standards:
F746 Test Method for Pitting or Crevice Corrosion of
F67 Specification for Unalloyed Titanium, for Surgical Im-
Metallic Surgical Implant Materials
plant Applications (UNS R50250, UNS R50400, UNS
F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of Alloy Forgings for Surgical Implants (UNS R31537,
Subcommittee F04.22 on Arthroplasty.
R31538, R31539)
Current edition approved Nov. 1, 2012. Published April 2013. Originally
F981 Practice for Assessment of Compatibility of Biomate-
approved in 2001. Last previous edition approved in 2011 as F2083 – 11. DOI:
rials for Surgical Implants with Respect to Effect of
10.1520/F2083-12.
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
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2083−12
Materials on Muscle and Bone Control and Corresponding Environmental Conditions for
F983 Practice for Permanent Marking of Orthopaedic Im- Test
plant Components
2.3 FDA Document:
5
F1044 Test Method for Shear Testing
...

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 − 11 F2083 − 12
Standard Specification for
1
Total 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 covers total knee replacement (TKR) is intended to cover all the widely used generic types of knee
replacement prostheses used to provide functioning articulation by employing femoral and tibial components, allowing a minimum
of 110° of flexion to high flexion. 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. 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. 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;
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:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
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
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant
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 Dec. 1, 2011Nov. 1, 2012. Published December 2011April 2013. Originally approved in 2001. Last previous edition approved in 20102011 as
F2083 – 10.F2083 – 11. DOI: 10.1520/F2083-11.10.1520/F2083-12.
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 the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2083 − 12
3
Applications (UNS R30563) (Withdrawn 2005)
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical
3
Implant Applications (Withdrawn 2012)
F746
...