Designation:F1223−14StandardTestMethodforDeterminationofTotalKneeReplacementConstraint1ThisstandardisissuedunderthefixeddesignationF1223;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoverstheestablishmentofadatabaseoftotalkneereplacement(TKR)motioncharacteristicswiththeintentofdevelopingguidelinesfortheassignmentofconstraintcriteriatoTKRdesigns.(SeetheRationaleinAppendixX1.)1.2ThistestmethodcoversthemeansbywhichaTKRconstraintmaybequantifiedaccordingtomotiondelineatedbytheinherentarticulardesignasdeterminedunderspecificloadingconditionsinaninvitroenvironment.1.3Testsdeemedapplicabletotheconstraintdeterminationareantero-posteriordraw,medio-lateralshear,rotarylaxity,valgus-varusrotation,anddistraction,asapplicable.Alsocoveredistheidentificationofgeometricalparametersofthecontactingsurfaceswhichwouldinfluencethismotionandthemeansofreportingthetestresults.(SeePracticesE4.)1.4Thistestmethodisnotaweartest.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E4PracticesforForceVerificationofTestingMachinesF2083SpecificationforKneeReplacementProsthesis3.Terminology3.1Definitions—Itemsinthiscategoryrefertothegeo-metricalandkinematicaspectsofTKRdesignsastheyrelatetotheirhumancounterparts:3.1.1anteriorcurvature,n—acondylardesignwhichisgenerallyplanarexceptforaconcave—upwardregionanteri-orlyonthetibialcomponent.3.1.2anteriorposterior(AP),n—anygeometricallengthalignedwiththeAPorientation.3.1.3APdisplacement,n—ther...
