ASTM_F_1357_-_14.pdf

Designation:F135714Standard Specification forArticulating Total Wrist Implants1This standard is issued under the fixed designation F1357;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 describes total wrist implants,includ-ing solid ceramic implants,used to provide functioning articu-lation by employing radial and carpal components.1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces,one-piece elastomeric im-plants(with or without grommets),and those devices used forcustom applications.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.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)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)3F601 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 ComponentsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants(UNS R56406)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)2.2 ANSI/ASME Standard:ANSI/ASME B46.1 Surface Texture(Surface Roughness,Waviness,and Lay)43.Terminology3.1 Definitions:1This 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 Nov.15,2014.Published January 2015.Originallyapproved in 1991.Last previous edition approved in 2009 as F1357 09.DOI:10.1520/F1357-14.2For 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,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 carpal componentarticulating member inserted intoor through the carpal bones.3.1.2 radial componentarticulating member inserted intothe radius for articulation with the carpal component.3.1.3 total wrist replacementprosthetic parts substitutedfor the native opposing radial and carpal articulating surfaces.4.Classification4.1 ConstrainedA constrained joint prosthesis is used forjoint replacement and prevents dislocation of the prosthesis inmore than one anatomical plane and consists of either a single,flexible,across-the-joint component,or more than one compo-nent linked together or affined.4.2 Partially ConstrainedA semi-constrained joint pros-thesis is used for partial or total joint replacement and limitstranslation and rotation of the prosthesis in one or more planesvia the geometry of its articulating surfaces.I