ASTM F 2665 : 2009 : R2014
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Standard Specification for Total Ankle Replacement Prosthesis
Available format(s)
Hardcopy , PDF
Superseded date
04-10-2021
Language(s)
English
Published date
09-24-2014
CONTAINED IN VOL. 13.01, 2015 Specifies total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15 degree of dorsiflexion and 15 to 25 degree (1) of plantar flexion, as determined by non-clinical testing.
1.1This 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.
1.2Included 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.
1.3This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to in vivo performance of the prosthesis are defined.
1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5This 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.
| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
7
|
| ProductNote |
Reconfirmed 2014
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ASTM F 1044 : 2005 : R2011 : EDT 1 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
| ASTM F 1160 : 2005 : R2011 : EDT 1 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 86 : 2013 : REDLINE | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
| ASTM F 1223 : 2004 : REV A | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1223 : 2004 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1377 : 1998 : REV A | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS-R30075) |
| ASTM F 1580 : 1995 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| ASTM F 565 : 2004 : R2009 | Standard Practice for Care and Handling of Orthopedic Implants and Instruments |
| ASTM F 1800 : 2019 : EDT 1 | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 563 : 2000 | Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005) |
| ASTM F 1223 : 2008 : R2012 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1108 : 2002 | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| ASTM F 1537 : 2011 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1472 : 2002 : REV A | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 1472 : 2014 : REDLINE | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 90 : 2014 : REDLINE | Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) |
| ASTM F 1108 : 1997 : REV A | Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406) |
| ASTM F 1160 : 2005 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 1108 : 2004 : R2009 | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| ASTM F 1108 : 2004 | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| ASTM F 1147 : 1999 | Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings |
| ASTM F 1377 : 2013 : REDLINE | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 1147 : 2005 : R2011 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| ASTM F 136 : 2013 : REDLINE | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ASTM F 1044 : 2005 : R2017 : EDT 1 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
| ASTM F 451 : 2016 | Standard Specification for Acrylic Bone Cement |
| ASME B46.1 : 2009 | SURFACE TEXTURE (SURFACE ROUGHNESS, WAVINESS, AND LAY) |
| ASTM F 1814 : 1997 : REV A | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1472 : 2000 | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications |
| ASTM F 1147 : 2005 | Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings |
| ASTM F 1108 : 2014 | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| ASTM F 1160 : 2000 : EDT 1 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 1800 : 1997 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1537 : 2008 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1223 : 2014 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 732 : 2017 : REDLINE | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| ASTM F 1223 : 2003 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1580 : 2018 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| ASTM F 1537 : 2007 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1377 : 2013 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 1472 : 2008 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 1377 : 2004 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 1108 : 2014 : REDLINE | Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| ASTM F 1223 : 2005 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1800 : 2019 | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1814 : 2015 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1044 : 1999 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
| ASTM F 1472 : 2014 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 1800 : 2004 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1537 : 2020 | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1800 : 2007 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 1160 : 2014 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 1580 : 2007 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| ISO 6474:1994 | Implants for surgery Ceramic materials based on high purity alumina |
| ASTM F 1537 : 2011 : REDLINE | Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1223 : 2014 : REDLINE | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1580 : 2001 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| ASTM F 1472 : 1999 | Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications |
| ASTM F 1814 : 2015 : REDLINE | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1160 : 2014 : R2017 : EDT 1 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 1814 : 1997 : REV A : R2003 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1537 : 2000 | Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| ASTM F 1160 : 2000 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| ASTM F 1377 : 2008 | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ASTM F 1800 : 2012 | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1800 : 2012 : REDLINE | Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1814 : 1997 : REV A : R2009 | Standard Guide for Evaluating Modular Hip and Knee Joint Components |
| ASTM F 1147 : 2005 : R2017 : EDT 1 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| ISO 14243-2:2016 | Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
| ASTM F 799 : 2011 : REDLINE | SPECIFICATION FOR COBALT-28CHROMIUM-6MOLYBDENUM ALLOY FORGINGS FOR SURGICAL IMPLANTS (UNS R31537, R31538, R31539) |
| ASTM F 1223 : 1996 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 1044 : 2005 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings |
| ASTM F 1223 : 2001 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| ASTM F 562 : 2013 : REDLINE | Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| ASTM F 1472 : 2008 : EDT 1 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| ASTM F 648 : 2014 : REDLINE | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| ASTM F 1580 : 2012 | Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants |
| ASTM F 1223 : 2008 | Standard Test Method for Determination of Total Knee Replacement Constraint |
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