ASTM F2665-21
(Specification)Standard Specification for Total Ankle Replacement Prosthesis
Standard Specification for Total Ankle Replacement Prosthesis
SCOPE
1.1 This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1)2 of plantar flexion, as determined by non-clinical testing.
1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in-vivo performance of the prosthesis are defined.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2665 −21
Standard Specification for
1
Total Ankle Replacement Prosthesis
This standard is issued under the fixed designation F2665; 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 2. Referenced Documents
3
1.1 This specification covers total ankle replacement (TAR) 2.1 ASTM Standards:
prostheses used to provide functioning articulation by employ- F67 Specification for Unalloyed Titanium, for Surgical Im-
ing talar and tibial components that allow for a minimum of plant Applications (UNS R50250, UNS R50400, UNS
2
15° of dorsiflexion and 15 to 25° (1) of plantar flexion, as R50550, UNS R50700)
determined by non-clinical testing. F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
1.2 Included within the scope of this specification are ankle
(UNS R30075)
componentsforprimaryandrevisionsurgerywithmodularand
F86 Practice for Surface Preparation and Marking of Metal-
non-modulardesigns,bearingcomponentswithfixedormobile
lic Surgical Implants
bearing designs, and components for cemented and/or cement-
F90 Specification for Wrought Cobalt-20Chromium-
less use.
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
1.3 This specification is intended to provide basic descrip-
tions (UNS R30605)
tions of material and prosthesis geometry. In addition, those
F136 Specification for Wrought Titanium-6Aluminum-
characteristics determined to be important to the in-vivo
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
performance of the prosthesis are defined.
Implant Applications (UNS R56401)
1.4 The values stated in SI units are to be regarded as F138 Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar andWire for Surgical
standard. No other units of measurement are included in this
standard. Implants (UNS S31673)
F451 Specification for Acrylic Bone Cement
1.5 This standard does not purport to address all of the
F561 Practice for Retrieval and Analysis of Medical
safety concerns, if any, associated with its use. It is the
Devices, and Associated Tissues and Fluids
responsibility of the user of this standard to establish appro-
F562 Specification for Wrought 35Cobalt-35Nickel-
priate safety, health, and environmental practices and deter-
20Chromium-10Molybdenum Alloy for Surgical Implant
mine the applicability of regulatory limitations prior to use.
Applications (UNS R30035)
1.6 This international standard was developed in accor-
F648 Specification for Ultra-High-Molecular-Weight Poly-
dance with internationally recognized principles on standard-
ethylene Powder and Fabricated Form for Surgical Im-
ization established in the Decision on Principles for the
plants
Development of International Standards, Guides and Recom-
F732 Test Method for Wear Testing of Polymeric Materials
mendations issued by the World Trade Organization Technical
Used in Total Joint Prostheses
Barriers to Trade (TBT) Committee.
F746 Test Method for Pitting or Crevice Corrosion of
Metallic Surgical Implant Materials
1 F748 PracticeforSelectingGenericBiologicalTestMethods
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of for Materials and Devices
Subcommittee F04.22 on Arthroplasty.
Current edition approved April 1, 2021. Published April 2021. Originally
3
approved in 2009. Last previous edition approved in 2014 as F2665 – 09 (2014). For referenced ASTM standards, visit the ASTM website, www.astm.org, or
DOI: 10.1520/F2665-21. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parentheses refer to a list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2665 − 21
F799 Specification for Cobalt-28 Chromium-6 Molybdenum ISO 13779-2 Implants for surgery—Hydroxyapatite—Part
Alloy Forgings for Surgical Implants (UNS R31537, 2: Thermally sprayed coatings of hydroxyapatite
R31538, R31539) ISO 14243-2 Implants for Surgery—Wear of Total Knee-
F981 Practice for Assessment of Compatibility of Biomate- Joint Prostheses—Part 2: Methods of Measurement
rials for Surgical Implants with Respect to Effect o
...
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: F2665 − 09 (Reapproved 2014) F2665 − 21
Standard Specification for
1
Total Ankle Replacement Prosthesis
This standard is issued under the fixed designation F2665; 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 ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar
2
and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1) of plantar flexion, as determined by
non-clinical testing.
1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and
non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless
use.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those
characteristics determined to be important to inthe vivoin-vivo performance of the prosthesis are defined.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of
the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
3
2.1 ASTM Standards:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
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 July 15, 2014April 1, 2021. Published September 2014April 2021. Originally approved in 2009. Last previous edition approved in 20092014
as F2665F2665 – 09 (2014). - 09. DOI: 10.1520/F2665-09R14.10.1520/F2665-21.
2
The boldface numbers in parentheses refer to a list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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 ----------------------
F2665 − 21
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
F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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
4
Applications (UNS R30563) (Withdrawn 2005)
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder
...
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