Designation:F1357−14StandardSpecificationforArticulatingTotalWristImplants1ThisstandardisissuedunderthefixeddesignationF1357;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationdescribestotalwristimplants,includ-ingsolidceramicimplants,usedtoprovidefunctioningarticu-lationbyemployingradialandcarpalcomponents.1.2Thisspecificationexcludesthoseimplantswithceramic-coatedorporous-coatedsurfaces,one-pieceelastomericim-plants(withorwithoutgrommets),andthosedevicesusedforcustomapplications.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F67SpecificationforUnalloyedTitanium,forSurgicalIm-plantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)F75SpecificationforCobalt-28Chromium-6MolybdenumAlloyCastingsandCastingAlloyforSurgicalImplants(UNSR30075)F86PracticeforSurfacePreparationandMarkingofMetal-licSurgicalImplantsF90SpecificationforWroughtCobalt-20Chromium-15Tungsten-10NickelAlloyforSurgicalImplantApplica-tions(UNSR30605)F136SpecificationforWroughtTitanium-6Aluminum-4VanadiumELI(ExtraLowInterstitial)AlloyforSurgicalImplantApplications(UNSR56401)F562SpecificationforWrought35Cobalt-35Nickel-20Chromium-10MolybdenumAlloyforSurgicalImplantApplications(UNSR30035)F563SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5IronAlloyforSurgicalImplantApplications(UNSR30563)(With-drawn2005)3F601PracticeforFluorescentPenetrantInspectionofMe-tallicSurgicalImplantsF603SpecificationforHigh-PurityDenseAl...
