ASTM_F_2091_-_15.pdf

Designation:F209115Standard Specification forAcetabular Prostheses1This standard is issued under the fixed designation F2091;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 acetabular resurfacing devicesused to provide a functioning articulation between the bones ofthe acetabulum and the femur.1.2 This specification is intended to provide basic descrip-tions of materials and device geometry.Additionally,thosecharacteristics determined to be important to in vivo perfor-mance of the device are defined.1.3 Acetabular prostheses included within the scope of thisspecification are intended for fixation by press-fit between theprosthesis and host bone,the use of bone cement,the use ofbone screws or similar means of mechanical fixation,orthrough biological fixation of host bone and/or soft connectivetissue into a porous surface.1.4 Custom(designed explicitly for a single patient),revision,or constrained acetabular prostheses are not coveredwithin the scope of this specification.1.5 This specification does not cover the details for qualityassurance,design control,production control contained in 21CFR 820(Quality System Regulation)and ISO 9001.2.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)F601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF629 Practice for Radiography of Cast Metallic SurgicalImplantsF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF746 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 ComponentsF1044 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 CoatingsF1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic Coatings1This 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 2001.Last previous edition approved in 2012 as F2091 01(2012).DOI:10.1520/F2091-15.2For 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 F1185 Specification for Composition of Hydroxylapatite forSurgical ImplantsF1377 Specification for Cobalt-28Chromium-6MolybdenumPowder for Coating of Orthopedic Implants(UNSR30075)F1472 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 ImplantsF1714 Guide for Gravimetric WearAssessment of ProstheticHip Designs in Simulator DevicesF1820 Test Method for Determining the Forces for Disas-sembly of Modular Acetabular DevicesF1978 Test Method for Measuring Abrasion Resistance ofMetallic Ther