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, 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.

General Information

Status
Historical
Publication Date
31-Oct-2004
Current Stage
Ref Project

Relations

Buy Standard

Technical specification
ASTM F2083-04 - Standard Specification for Total Knee Prosthesis
English language
7 pages
sale 15% off
Preview
sale 15% off
Preview

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 – 04
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 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 (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 (UNS
description of this component is excluded here since it is
R56401) for Surgical ImplantApplications (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 Cobalt-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
for Surgical Implant Applications (UNS R30563)
characteristics determined to be important to in vivo perfor-
F 565 Practice for Care and Handling of Orthopedic Im-
mance of the prosthesis are defined.
plants and Instruments
1.4 Excluded from the scope are hemiarthroplasty devices
F 648 Specification for Ultra-High-Molecular-Weight Poly-
that replace only the femoral or tibial surface, but not both;
ethylene Powder and Fabricated Form for Surgical Im-
unicompartmental designs, which replace the articulating sur-
plants
faces of only one condyle; and patellofemoral prostheses.Also
F 732 Test Method for Wear Testing for Polymeric Materi-
excluded are devices designed for custom applications.
als for Use in Total Joint Prostheses
2. Referenced Documents
F 745 Specification for 18 Chromium-12.5 Nickel-2.5 Mo-
2
lybdenum Stainless Steel for Cast and Solution-Annealed
2.1 ASTM Standards:
Surgical Implant Applications
F67 Specification for Unalloyed Titanium for Surgical
F 746 Test Method for Pitting or Crevice Corrosion of
Implant Applications (UNS R50250, UNS R50400, UNS
Metallic Surgical Implant Materials
R50550, UNS R50700)
F 748 Practice for Selecting Generic Biological Test Meth-
F75 Specification for Cobalt-28Chromium-6Molybdenum
ods for Materials and Devices
Alloy Castings and Casting Alloy for Surgical Implants
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
(UNS R30075)
Alloy for Surgical Implants (UNS R31537, R31538,
R31539)
1
This specification is under the jurisdiction of ASTM Committee F04 on
F 981 Practice for Assessment of Compatibility of Bioma-
Medical and Surgical Materials and Devices and is the direct responsibility of
terials for Surgical Implants with Respect to Effect of
Subcommittee F04.22 on Arthroplasty.
Material on Muscle and Bone
Current edition approved Nov. 1, 2004. Published November 2004. Originally
F 983 Practice for Permanent Marking of Orthopaedic Im-
approved in 2001. Last previous edition approved in 2003 as F 2083 – 03.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
plant Components
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F 1044 Test Method for Shear Testing of Calcium Phos-
Standards volume information, refer to the standard’s Document Summary page on
phate Coatings and Metallic Coatings
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
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.
F2083–04
F 1108 Specification for Titanium-6Aluminum-4Vanadium restrict unw
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.