ASTM_F_2665_-_09_2014.pdf

Designation:F266509(Reapproved 2014)Standard Specification forTotal Ankle Replacement Prosthesis1This standard is issued under the fixed designation F2665;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers total ankle replacement(TAR)prostheses used to provide functioning articulation by employ-ing talar and tibial components that allow for a minimum of15 of dorsiflexion and 15 to 25(1)2of plantar flexion,asdetermined by non-clinical testing.1.2 Included within the scope of this specification are anklecomponents for primary and revision surgery with modular andnon-modular designs,bearing components with fixed or mobilebearing designs,and components for cemented and/or cement-less use.1.3 This specification is intended to provide basic descrip-tions of material and prosthesis geometry.In addition,thosecharacteristics determined to be important to in vivo perfor-mance of the prosthesis are defined.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3F67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F451 Specification for Acrylic Bone CementF562 SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F563 SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications(UNS R30563)(With-drawn 2005)4F565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF745 Specificationfor18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications(Withdrawn2012)4F746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved July 15,2014.Published September 2014.Originallyapproved in 2009.Last previous edition approved in 2009 as F2665-09.DOI:10.1520/F2665-09R14.2The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.4The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants(UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF1223 Test Method for Determination of Total Knee Re-placement ConstraintF1377 Specification for Cobalt-28Chromium-6MolybdenumPowder for Coating of Ort