ASTM_F_2068_-_15.pdf

Designation:F206815Standard Specification forFemoral ProsthesesMetallic Implants1This standard is issued under the fixed designation F2068;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers metallic stemmed femoralprostheses used to replace the natural hip joint by means ofhemi-arthroplasty or total hip surgical procedures.Prosthesesfor hemi-arthroplasty are intended to articulate with the naturalacetabulum of the patient.Prostheses for total hip replacementare intended to articulate with prosthetic acetabular cups.Prostheses may have integral femoral heads or cones designedto accept modular heads.1.2 Modular femoral heads,which may be affixed to coneson implants covered by this specification,are not covered bythis specification.The mechanical strength,corrosionresistance,and biocompatibility of the head portions of one-piece integral implants are covered by this specification.1.3 Femoral prostheses included within the scope of thisspecification are intended for fixation by press fit between theprosthesis and host bone,the use of bone cement,or throughthe ingrowth of host bone into a porous coating.1.4 Custom femoral prostheses,designed explicitly for asingle patient,are not covered within the scope of thisspecification.1.5 Prostheses incorporating nonmetallic(for example,polymer composite)implants,nonporous bioactive ceramiccoatings,or porous-polymer coatings,are specifically excludedfrom the scope of this specification.1.6 The requirements for modular connections of multicom-ponent modular femoral hip prostheses are not covered by thisspecification.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F562 SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F620 Specification for Titanium Alloy Forgings for SurgicalImplants in the Alpha Plus Beta ConditionF746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)F981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF983 Practice for Permanent Marking of Orthopaedic Im-plant Components1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved March 15,2015.Published May 2015.Originallyapproved in 2000.Last previous edition approved in 2009 as F2068 09.DOI:10.1520/F2068-15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants(UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications(UNSR56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)F1580 SpecificationforTitaniumandTitanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants(UNS S31675)F1813 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant(UNSR58120)F1814 Gui