ASTM F2083-03

Standard Specification for Total Knee Prosthesis

SCOPE
1.1 This specification covers total knee replacement (TKR) prostheses used to provide functioning articulation by employing femoral and tibial components. 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.

General Information

• Status: Historical
• Publication Date: 09-Apr-2003
• 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 F2083-01a - Standard Specification for Total Knee Prosthesis
• Effective Date: 10-Apr-2003
• Replaced By: ASTM F2083-04 - Standard Specification for Total Knee Prosthesis
• Effective Date: 01-Nov-2004
• Referred By: ASTM F1800-19e1 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2722-21 - Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
• Effective Date: 10-Apr-2003
• Referred By: ASTM F3140-23 - Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
• Effective Date: 10-Apr-2003
• Referred By: ASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
• Effective Date: 10-Apr-2003
• Referred By: ASTM F3495-23 - Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2777-23 - Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Apr-2003

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 – 03
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy (UNS
1.1 This specification covers total knee replacement (TKR)
R56401) for Surgical Implant Applications (UNS
prostheses used to provide functioning articulation by employ-
2
R56401)
ing femoral and tibial components. Although a patellar com-
F 138 Specification for Wrought 18Chromium-14Nickel-
ponent may be considered an integral part of a TKR, the
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
detailed description of this component is excluded here since it
2
Implants (UNS S31673)
is provided in Specification F 1672.
2
F 451 Specification for Acrylic Bone Cement
1.2 Included within the scope of this specification are
F 562 Specification for Wrought Cobalt-35Nickel-
replaceable components of modular designs, for example, tibial
20Chromium-10Molybdenum Alloy for Surgical Implant
articulating surfaces and all components labeled for or capable
2
Applications (UNS R30035)
of being used with cement, regardless of whether the same
F 563 Specification for Wrought Cobalt-20Nickel-
components can also be used without cement. This includes
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
primary and revision prostheses and also covers fixed and
2
for Surgical Implant Applications (UNS R30563)
mobile bearing knee designs.
F 565 Practice for Care and Handling of Orthopedic Im-
1.3 This specification is intended to provide basic descrip-
2
plants and Instruments
tions of material and prosthesis geometry. Additionally, those
F 648 Specification for Ultra-High-Molecular-Weight Poly-
characteristics determined to be important to in vivo perfor-
ethylene Powder and Fabricated Form for Surgical Im-
mance of the prosthesis are defined.
2
plants
1.4 Excluded from the scope are hemiarthroplasty devices
F 732 Test Method for Wear Testing for Polymeric Materi-
that replace only the femoral or tibial surface, but not both;
2
als for Use in Total Joint Prostheses
unicompartmental designs, which replace the articulating sur-
F 745 Specification for 18 Chromium-12.5 Nickel-2.5 Mo-
faces of only one condyle; and patellofemoral prostheses. Also
lybdenum Stainless Steel for Cast and Solution-Annealed
excluded are devices designed for custom applications.
2
Surgical Implant Applications
2. Referenced Documents F 746 Test Method for Pitting or Crevice Corrosion of
2
Metallic Surgical Implant Materials
2.1 ASTM Standards:
F 748 Practice for Selecting Generic Biological Test Meth-
F 67 Specification for Unalloyed Titanium for Surgical
2
ods for Materials and Devices
Implant Applications (UNS R50250, UNS R50400, UNS
2
F 799 Specification for Cobalt-28Chromium-6Molybdenum
R50550, UNS R50700)
Alloy for Surgical Implants (UNS R31537, R31538,
F 75 Specification for Cobalt-28Chromium-6Molybdenum
2
R31539)
Alloy Castings and Casting Alloy for Surgical Implants
2
F 981 Practice for Assessment of Compatibility of Bioma-
(UNS R30075)
terials for Surgical Implants with Respect to Effect of
F 86 Practice for Surface Preparation and Marking of Me-
2
2
Material on Muscle and Bone
tallic Surgical Implants
F 983 Practice for Permanent Marking of Orthopaedic Im-
F 90 Specification for Wrought Cobalt-20Chromium-
2
plant Components
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
2
F 1044 Test Method for Shear Testing of Calcium Phos-
tions (R30605)
2
phate Coatings and Metallic Coatings
F 1108 Specification for Titanium-6Aluminum-4Vanadium
1 2
This specification is under the jurisdiction of ASTM Committee F04 on
Alloy Castings for Surgical Implants (UNS R56406)
Medical and Surgical Materials and Devices and is the direct responsibility of
F 1147 Test Method for Tension Testing of Calcium Phos-
Subcommittee F04.22 on Arthroplasty.
2
phate and Metallic Coatings
Current edition approved Apr. 10, 2003. Published May 2003. Originally
approved in 2001. Last previous edition approved in 2001 as F 2083 - 01a.
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2083–03
F 1160 Test Method for Shear and Bending Fatigue Testing 3.1.7 radiographic marker, n—a nonstructural, generally
of Calcium Phosphate and Metallic Medical and Compos- thin wire, designed to be apparent on X-rays taken after
2
ite Calcium Phosph
...