ASTM F2083-01

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

• Replaced By: ASTM F2083-01a - Standard Specification for Total Knee Prosthesis
• Effective Date: 10-Jun-2001
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-Jun-2001
• 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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2083 – 01
Standard Specification for
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 Implants (UNS S31673)
F 451 Specification for Acrylic Bone Cement
1.1 This specification covers total knee replacement (TKR)
F 562 Specification for Wrought Cobalt-35 Nickel-20
prostheses used to provide functioning articulation by employ-
Chromium-10 Molybdenum Alloy for Surgical Implant
ing femoral and tibial components. Although a patellar com-
Applications (UNS R30035)
ponent may be considered an integral part of a TKR, the
F 563 Specification for Wrought Cobalt-20Nickel-
detailed description of this component is excluded here since it
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
is provided in Specification F 1672.
for Surgical Implant Applications (UNS R30563)
1.2 Included within the scope of this specification are
F 565 Practice for Care and Handling of Orthopedic Im-
replaceable components of modular designs, for example, tibial
plants and Instruments
articulating surfaces, and all components labeled for or capable
F 648 Specification for Ultra-High-Molecular-Weight Poly-
of being used with cement, regardless of whether the same
ethylene Powder and Fabricated Form for Surgical Im-
components can also be used without cement.
plants
1.3 This standard is intended to provide basic descriptions
F 732 Test Method for Wear Testing for Polymeric Materi-
of material and prosthesis geometry. Additionally, those char-
als Used in Total Joint Prostheses
acteristics determined to be important to in-vivo performance
F 745 Specification for 18 Chromium-12.5 Nickel-2.5 Mo-
of the prosthesis are defined.
lybdenum Stainless Steel for Cast and Solution-Annealed
1.4 Excluded from the scope are hemiarthroplasty devices
Surgical Implant Applications
which replace only the femoral or tibial surface, but not both;
F 746 Test Method for Pitting or Crevice Corrosion of
unicompartmental designs, which replace the articulating sur-
Metallic Surgical Implant Materials
faces of only one condyle, and, patellofemoral prostheses. Also
F 748 Practice for Selecting Generic Biological Test Meth-
excluded are devices designed for custom applications.
ods for Materials and Devices
2. Referenced Documents F 799 Specification for Cobalt-28 Chromium-6 Molybde-
num Alloy for Surgical Implants (UNS R31537, R31538,
2.1 ASTM Standards:
R31539)
F 67 Specification for Unalloyed Titanium (UNS R50250,
F 981 Practice for Assessment of Compatibility of Bioma-
UNS R50400, UNS R50550, UNS R50700) for Surgical
terials for Surgical Implants with Respect to Effect of
Implant Applications
Material on Muscle and Bone
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
F 983 Practice for Permanent Marking of Orthopaedic Im-
Casting Alloy and Cast Products for Surgical Implants
plant Components
(UNS R30075)
F 1044 Test Method for Shear Testing of Calcium Phos-
F 86 Practice for Surface Preparation and Marking of Me-
phate Coatings and Metallic Coatings
tallic Surgical Implants
F 1108 Specification for Titanium-6 Aluminum-4 Vanadium
F 90 Specification for Wrought Cobalt-20 Chromium-15
Alloy Castings for Surgical Implants (UNS R56406)
Tungsten-10 Nickel Alloy for Surgical Implant Applica-
F 1147 Test Method for Tension Testing of Calcium Phos-
tions (R30605)
phate and Metallic Coatings
F 136 Specification for Wrought Titanium-6 Aluminum-4
F 1160 Test Method for Shear and Bending Fatigue Testing
Vanadium ELI (Extra Low Interstitial) Alloy (UNS
of Calcium Phosphate and Metallic Medical and Compos-
R56401) for Surgical Implant Applications
ite Calcium Phosphate/Metallic Coatings
F 138 Specification for Wrought 18 Chromium-14 Nickel-
F 1223 Test Method for Determination of Total Knee Re-
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
placement Constraint
F 1472 Specification for Wrought Titanium-6 Aluminum-4
This specification is under the jurisdiction of ASTM Committee F04 on
Vanadium Alloy (UNS R56400) for Surgical Implant
Medical and Surgical Materials and Devices and is the direct responsibility of
Applications
Subcommittee F04.22 on Arthroplasty.
Current edition approved Feb. 10, 2001. Published April 2001.
F 1537 Specification for Wrought Cobalt-28 Chromium-6
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 2083
Molybdenum Alloy for Surgical Implants (UNS R31537, 4. Classification
UNS R31538, and UNS R31529)
4.1 The following classification by degree of constraint is
F 1580 Specification for Titanium and Titanium-6 %
suggested based on the concepts adopted by the U.S. Food and
Aluminum-4 % Vanadium Alloy Powders for Coatings of
Drug Administration (see 2.3).
Surgical Implants
4.1.1 Constrained—A constrained joint prosthesis prevents
F 1672 Specification for Resurfacing Patellar Prosthesis
dislocation of the prosthesis in more than one anatomic plane
F 1715 Guide for Wear Assessment of Prosthetic Knee
and consists of either a single, flexible, across-the-joint com-
Designs in Simulator Devices
ponent or more than one component linked together or affined.
F 1800 Test Method for Cyclic Fatigue Testing of Metal
4.1.2 Semi-Constrained—A semi-constrained joint prosthe-
Tibial Tray Components of Total Knee Joint Replace-
sis limits translation and/or rotation of the prosthesis in one or
ments
more planes via the geometry of its articulating surfaces. It has
F 1814 Guide for Evaluating Modular Hip and Knee Joint
no across-the-joint linkages.
Replacement Components
4.1.3 Nonconstrained—A nonconstrained joint prosthesis
2.2 ISO Standard:
minimally restricts prosthesis movement in one or more planes.
ISO 6474 Implants for Surgery—Ceramic Materials Based
Its components have no across-the-joint linkages.
on Alumina
5. Material
2.3 FDA Document:
5.1 The choice of materials is understood to be a necessary
US FDA 21 CFR 888.6 Degree of Constraint
but not sufficient assurance of function of the device made
2.4 ANSI/ASME Standard:
from them. All devices conforming to this specification shall be
ANSI/ASME B46.1-1995, Surface Texture (Surface Rough-
fabricated from materials with adequate mechanical strength
ness, Waviness, and Lay)
and durability, corrosion resistance, and biocompatibility.
3. Terminology 5.1.1 Mechanical Strength—Various components of total
knee replacement devices have been successfully fabricated
3.1 Definitions of Terms Specific to This Standard:
from the following materials. See Specifications F 75, F 90,
3.1.1 constraint, n—the relative inability of a TKR to be
F 136, F 138, F 562, F 563, F 745, F 799, F 1108, F 1472,
further displaced in a specific direction under a given set of
F 1537, and F 1580. Polymeric bearing components have been
loading conditions as dictated by the TKR’s geometric design.
fabricated from UHMWPE as specified in Specification F 648.
3.1.2 extension, n—motion of the tibia toward bringing it
Porous coatings have been fabricated from the materials
into axial alignment with the femur.
specified in Specifications F 67 and F 75. Not all of these
3.1.3 femoral component, n—bearing member fixed to the
materials may possess sufficient mechanical strength for criti-
femur for articulation with the tibial component and the
cal highly-stressed components nor for articulating surfaces.
patellar component or natural patella.
5.1.2 Corrosion Resistance—Materials with limited or no
3.1.4 flexion, n—motion of the tibia toward bringing it into
history of successful use for orthopaedic implant application
contact with the posterior femoral surface.
must be determined to exhibit corrosion resistance equal to or
3.1.5 interlock, n—the mechanical design feature used to
better than one of the materials listed in 5.1.1 when tested in
increase capture of one component within another and to
accordance to Test Method F 746.
restrict unwanted displacement between components, that is,
5.1.3 Biocompatibility—Materials with limited or no his-
component locking mechanism for modular components.
tory of successful use for orthopaedic implant application must
3.1.6 patella component, n—bearing member fixed to the
be determined to exhibit acceptable biological response equal
natural patella for articulation with the femoral component,
to or better than one of the materials listed in 5.1.1 when tested
which is described in Specification F 1672.
in accordance with Practices F 748 and F 981 for a given
3.1.7 radiographic marker, n—a nonstructural, generally
application.
thin wire, designed to be apparent on X-rays taken after
implantation for those components that would otherwise be
6. Performance Requirements
nonapparent on such X-rays.
6.1 Component Function—Each component for total knee
3.1.8 tibial component, n—bearing member fixed to the
arthroplasty is expected to function as intended when manu-
tibia for articulation with the femoral component, typically
factured in accordance with good manufacturing practices and
either monoblock UHMWPE or consisting of two major
to the requirements of this specification. The components shall
components, a metallic tibial tray and a UHMWPE bearing
be capable of withstanding static and dynamic physiologic
surface.
loads without compromise to their function for the intended use
3.1.9 total knee replacement (TKR), n—prosthetic parts that
and environment. All components used for experimental mea-
substitute for the natural opposing tibial, patellar, and femoral
sures of performance shall be equivalent to the finished product
articulating surfaces.
in form and material. Components shall be sterilized if it will
affect their performance.
3 NOTE 1—Computer models may be used to evaluate many of the
Available from American National Standards Institute, 11 W. 42nd St., 13th
functional characteristics if appropriate material properties and functional
Floor, New York, NY 10036.
constraints are included and the computer models have been validated
Available from the Food and Drug Administration, Center for Devices and
Radiological Health, 1350 Piccard Dr., Rockville, MD 20850. with experimental tests.
F 2083
NOTE 3—In situations in which the pin-on-flat test may not be consid-
6.1.1 Individual tibial and femoral components may be
ered appropriate, other tests may be considered, that is, knee simulation
fatigue tested using relevant test methods under appropriate
modes of prosthesis wear performance testing or those described in ISO
loading conditions to address loss of supporting foundation
6474 or other published documents.
(see Test Method F 1800).
6.3.2 Functional wear tests also may be performed to
6.1.2 Contact area and contact pressure distributions may be
evaluate material and design performance. Since it is unlikely
determined at various flexion angles using one of several
5,6,7
that one set of test conditions can simulate all aspects of knee
published methods to provide a representation of stresses
function it is recommended that various test conditions be
applied to the bearing surfaces and to the components. Flexion
used. Among the simulated conditions, there should be consid-
angles of 0, 15, 30, 60, and 90° are recommended. If these tests
eration of the effect of third body abrasive interaction.
are performed, it is important to maintain consistent test
6.3.3 Evaluation of wear may be done gravimetrically in
parameters and to evaluate other TKR prostheses under the
accordance with Guide F 1715. Consideration should also be
same conditions.
given to other evaluation methods such as volumetric measure-
6.1.3 Range of motion in flexion/extension shall be greater
ments through the use of contact and noncontact profilometry
than or equal to 0°, flexion shall be greater than or equal to
and three dimensional scanning techniques; semiquantitative
110°. These measurements apply to components mounted in
measures of damage assessment; and measurement of friction
neutral alignment in bone or in an anatomically representative
factors.
substitute. It may be useful to define the location of the neutral
6.3.4 It may be important to understand the characteristics
alignment position, for example, center of contact areas or
of debris generated during the wear tests. Wear debris gener-
patches, in terms of dimensions from outside edges of the
ated from specific wear tests of new materials may be
components. The initial positioning or location of the neutral
characterized for morphology and size distribution and com-
alignment point will affect the range of motion values for
pared to wear debris from standard controls or to wear debris
certain TKR prostheses.
collected from in-vivo clinical service or animal studies. The
NOTE 2—If the TKR prosthesis does not meet the range of motion
wear debris also may be characterized for biological response
criteria mentioned above, then it must be described clearly on the
in accordance with Practice F 748.
packaging material for the prosthesis as mentioned in 9.4.
6.4 Porous metal coatings shall be tested in accordance with
6.1.4 Total knee replacement constraint data for internal-
Test Method F 1044 (shear strength) and Test Method F 1147
external rotation, anterior-posterior displacement, and medial-
(tensile strength) and the average for each test should exceed
lateral displacement may be determined in accordance with
20 MPa. The fatigue properties may be evaluated in accordance
Test Method F 1223. Testing implants at 0 and 90° of flexion at
with Test Method F 1160.
a minimum is recommended.
6.2 All modular components must be evaluated for the
7. Dimensions
integrity of their connecting mechanisms. As suggested in
7.1 Dimensions of total knee replacement components may
Guide F 1814, static and dynamic shear tests, bending tests,
be designated in accordance with Fig. 1 and the items specified
and tensile tests or any combination may be necessary to
in the glossary. The tolerance and methods of dimensional
determine the performance characteristics. The connection
measurement must be sought to conform with industry practice
mechanisms must show sufficient integrity for the range of
and, whenever possible, on an international basis.
loads anticipated for the application.
6.3 It is important to understand the wear performance for
8. Finishing and Marking
articulating surfaces. Any new or different material couple
8.1 Metallic components conforming to this specification
must not
...