Designation:F2665−09(Reapproved2014)StandardSpecificationforTotalAnkleReplacementProsthesis1ThisstandardisissuedunderthefixeddesignationF2665;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstotalanklereplacement(TAR)prosthesesusedtoprovidefunctioningarticulationbyemploy-ingtalarandtibialcomponentsthatallowforaminimumof15°ofdorsiflexionand15to25°(1)2ofplantarflexion,asdeterminedbynon-clinicaltesting.1.2Includedwithinthescopeofthisspecificationareanklecomponentsforprimaryandrevisionsurgerywithmodularandnon-modulardesigns,bearingcomponentswithfixedormobilebearingdesigns,andcomponentsforcementedand/orcement-lessuse.1.3Thisspecificationisintendedtoprovidebasicdescrip-tionsofmaterialandprosthesisgeometry.Inaddition,thosecharacteristicsdeterminedtobeimportanttoinvivoperfor-manceoftheprosthesisaredefined.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:3F67SpecificationforUnalloyedTitanium,forSurgicalIm-plantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)F75SpecificationforCobalt-28Chromium-6MolybdenumAlloyCastingsandCastingAlloyforSurgicalImplants(UNSR30075)F86PracticeforSurfacePreparationandMarkingofMetal-licSurgicalImplantsF90SpecificationforWroughtCobalt-20Chromium-15Tungsten-10NickelAlloyforSurgicalImplantApplica-tions(UNSR30605)F136SpecificationforWroughtTitanium-6Aluminum-4VanadiumELI(ExtraLowInterstitial)AlloyforSurgicalImplantApplications(UNSR56401)F138SpecificationforWrought18Chromium-1...
