ASTM_F_1378_-_12.pdf

Designation:F137812Standard Specification forShoulder Prostheses1This standard is issued under the fixed designation F1378;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 shoulder prostheses for total orhemiarthroplasty used to provide functioning articulation byemploying glenoid and humeral components.1.2 Devices for custom applications are not covered by thisspecification.Modular prostheses are included in this specifi-cation.1.3 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:2F75 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)F563 SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications(UNS R30563)(With-drawn 2005)3F603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF745 Specificationfor18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications(Withdrawn2012)3F746 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 CoatingsF1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)F1829 Test Method for Static Evaluation of Glenoid Lock-ing Mechanism in ShearF2028 Test Methods for Dynamic Evaluation of GlenoidLoosening or Disassociation2.2 ANSI Standard:4ASME B46.119951This 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 Jan.1,2012.Published January 2012.Originallyapproved in 1992.Last previous edition approved in 2010 as F1378 05(2010).DOI:10.1520/F1378-12.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 collarflange at the junction of the neck and stem.3.1.2 glenoid componentthe prosthetic portion thatreplaces,in part or in total,the glenoid fossa of the scapula andarticulates with the natural humeral head or a prostheticreplacement.3.1.3 headbearing member for articulation with the gle-noid.3.1.4 humeral componentthe prosthetic portion thatreplaces,in part or in toto,the proximal humerus or humeralhead and articulates with the natural glenoid fossa or aprosthetic replacement.3.1.5 keel,(or pegs)single or multiple projections thatprovide resistance to translation or rotation of the glenoidcomponent,or both,by mating with cavities created in theglenoid fossa.3.1.6 necksegment connecting the head and the stem.3.1.7 reverse design shoulder implantsimplants that havea ball-shaped glenoid component and a concave humeraldesign.3.1.8 stemsegment intended for insertion within the hu-meral medulla