Designation:F2068−15StandardSpecificationforFemoralProstheses—MetallicImplants1ThisstandardisissuedunderthefixeddesignationF2068;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversmetallicstemmedfemoralprosthesesusedtoreplacethenaturalhipjointbymeansofhemi-arthroplastyortotalhipsurgicalprocedures.Prosthesesforhemi-arthroplastyareintendedtoarticulatewiththenaturalacetabulumofthepatient.Prosthesesfortotalhipreplacementareintendedtoarticulatewithprostheticacetabularcups.Prosthesesmayhaveintegralfemoralheadsorconesdesignedtoacceptmodularheads.1.2Modularfemoralheads,whichmaybeaffixedtoconesonimplantscoveredbythisspecification,arenotcoveredbythisspecification.Themechanicalstrength,corrosionresistance,andbiocompatibilityoftheheadportionsofone-pieceintegralimplantsarecoveredbythisspecification.1.3Femoralprosthesesincludedwithinthescopeofthisspecificationareintendedforfixationbypressfitbetweentheprosthesisandhostbone,theuseofbonecement,orthroughtheingrowthofhostboneintoaporouscoating.1.4Customfemoralprostheses,designedexplicitlyforasinglepatient,arenotcoveredwithinthescopeofthisspecification.1.5Prosthesesincorporatingnonmetallic(forexample,polymercomposite)implants,nonporousbioactiveceramiccoatings,orporous-polymercoatings,arespecificallyexcludedfromthescopeofthisspecification.1.6Therequirementsformodularconnectionsofmulticom-ponentmodularfemoralhipprosthesesarenotcoveredbythisspecification.1.7ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.2.ReferencedDocuments2.1ASTMStandards:2F67SpecificationforUnalloyedTitanium,forSurgicalIm-plantApplications(UNSR50250,UNSR50400,UNSR50550,UNSR50700)F75SpecificationforCobalt-28Chromium-6MolybdenumAlloyCastingsandCastingAlloyforSurgicalImplants(UNS...
