ASTM F2083-01a

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 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 standard 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-Jun-2001
• 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 F2083-01 - Standard Specification for Total Knee Prosthesis
• Effective Date: 10-Jun-2001
• Replaced By: ASTM F2083-03 - Standard Specification for Total Knee Prosthesis
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1800-19e1 - Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
• Effective Date: 10-Jun-2001
• Referred By: ASTM F3495-23 - Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components
• Effective Date: 10-Jun-2001
• 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-Jun-2001
• Referred By: ASTM F3210-22e1 - Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
• Effective Date: 10-Jun-2001
• Referred By: ASTM F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
• Effective Date: 10-Jun-2001
• Referred By: ASTM F2722-21 - Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
• Effective Date: 10-Jun-2001
• Referred By: ASTM F2777-23 - Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
• Effective Date: 10-Jun-2001
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Jun-2001

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2083 – 01a
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 Vanadium ELI (Extra Low Interstitial) Alloy (UNS
2
R56401) for Surgical Implant Applications
1.1 This specification covers total knee replacement (TKR)
F 138 Specification for Wrought 18 Chromium-14 Nickel-
prostheses used to provide functioning articulation by employ-
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
ing femoral and tibial components. Although a patellar com-
2
Implants (UNS S31673)
ponent may be considered an integral part of a TKR, the
2
F 451 Specification for Acrylic Bone Cement
detailed description of this component is excluded here since it
F 562 Specification for Wrought Cobalt-35 Nickel-20
is provided in Specification F 1672.
Chromium-10 Molybdenum Alloy for Surgical Implant
1.2 Included within the scope of this specification are
2
Applications UNS R30035
replaceable components of modular designs, for example, tibial
F 563 Specification for Wrought Cobalt-20Nickel-
articulating surfaces and all components labeled for or capable
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
of being used with cement, regardless of whether the same
2
for Surgical Implant Applications (UNS R30563)
components can also be used without cement. This includes
F 565 Practice for Care and Handling of Orthopedic Im-
primary and revision prostheses and also covers fixed and
2
plants and Instruments
mobile bearing knee designs.
F 648 Specification for Ultra-High-Molecular-Weight Poly-
1.3 This standard is intended to provide basic descriptions
ethylene Powder and Fabricated Form for Surgical Im-
of material and prosthesis geometry. Additionally, those char-
2
plants
acteristics determined to be important to in-vivo performance
F 732 Test Method for Wear Testing for Polymeric Materi-
of the prosthesis are defined.
2
als Used in Total Joint Prostheses
1.4 Excluded from the scope are hemiarthroplasty devices
F 745 Specification for 18 Chromium-12.5 Nickel-2.5 Mo-
that replace only the femoral or tibial surface, but not both;
lybdenum Stainless Steel for Cast and Solution-Annealed
unicompartmental designs, which replace the articulating sur-
2
Surgical Implant Applications
faces of only one condyle; and patellofemoral prostheses. Also
F 746 Test Method for Pitting or Crevice Corrosion of
excluded are devices designed for custom applications.
2
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 Specification for Cobalt-28 Chromium-6 Molybde-
F 67 Specification for Unalloyed Titanium (UNS R50250,
num Alloy for Surgical Implants (UNS R31537, R31538,
UNS R50400, UNS R50550, UNS R50700) for Surgical
2
R31539)
Implant Applications
F 981 Practice for Assessment of Compatibility of Bioma-
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
terials for Surgical Implants with Respect to Effect of
Casting Alloy and Cast Products for Surgical Implants
2
2
Material on Muscle and Bone
(UNS R30075)
F 983 Practice for Permanent Marking of Orthopaedic Im-
F 86 Practice for Surface Preparation and Marking of Me-
2
plant Components
tallic Surgical Implants
F 1044 Test Method for Shear Testing of Calcium Phos-
F 90 Specification for Wrought Cobalt-20 Chromium-15
2
phate Coatings and Metallic Coatings
Tungsten-10 Nickel Alloy for Surgical Implant Applica-
2
F 1108 Specification for Titanium-6 Aluminum-4 Vanadium
tions (R30605)
2
Alloy Castings for Surgical Implants (UNS R56406)
F 136 Specification for Wrought Titanium-6 Aluminum-4
F 1147 Test Method for Tension Testing of Calcium Phos-
2
phate and Metallic Coatings
1
This specification is under the jurisdiction of ASTM Committee F04 on
F 1160 Test Method for Shear and Bending Fatigue Testing
Medical and Surgical Materials and Devices and is the direct responsibility of
of Calcium Phosphate and Metallic Medical and Compos-
Subcommittee F04.22 on Arthroplasty.
2
ite Calcium Phosphate/Metallic Coatings
Current edition approved June 10, 2001. Published June 2001. Originally
published as F 2083 - 01. Last previous edition F 2083 - 01.
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
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NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for th
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