Designation:F2091−15StandardSpecificationforAcetabularProstheses1ThisstandardisissuedunderthefixeddesignationF2091;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversacetabularresurfacingdevicesusedtoprovideafunctioningarticulationbetweenthebonesoftheacetabulumandthefemur.1.2Thisspecificationisintendedtoprovidebasicdescrip-tionsofmaterialsanddevicegeometry.Additionally,thosecharacteristicsdeterminedtobeimportanttoinvivoperfor-manceofthedevicearedefined.1.3Acetabularprosthesesincludedwithinthescopeofthisspecificationareintendedforfixationbypress-fitbetweentheprosthesisandhostbone,theuseofbonecement,theuseofbonescrewsorsimilarmeansofmechanicalfixation,orthroughbiologicalfixationofhostboneand/orsoftconnectivetissueintoaporoussurface.1.4Custom(designedexplicitlyforasinglepatient),revision,orconstrainedacetabularprosthesesarenotcoveredwithinthescopeofthisspecification.1.5Thisspecificationdoesnotcoverthedetailsforqualityassurance,designcontrol,productioncontrolcontainedin21CFR820(QualitySystemRegulation)andISO9001.2.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)F138SpecificationforWrought18Chromium-14Nickel-2.5MolybdenumStainlessSteelBarandWireforSurgicalImplants(UNSS31673)F562SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Mo...
