ASTM F2083-2010 Standard Specification for Total Knee Prosthesis《全膝关节置换标准规范》.pdf

1、Designation: F2083 10Standard Specification forTotal Knee Prosthesis1This standard is issued under the fixed designation F2083; 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 indi

2、cates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers total knee replacement (TKR)prostheses used to provide functioning articulation by employ-ing femoral and tibial components, allowing a

3、 minimum of110 of flexion to high flexion. Although a patellar componentmay be considered an integral part of a TKR, the detaileddescription of this component is excluded here since it isprovided in Specification F1672.1.2 Included within the scope of this specification arereplaceable components of

4、modular designs, for example, tibialarticulating surfaces and all components labeled for, or capableof, being used with cement, regardless of whether the samecomponents can also be used without cement. This includesprimary and revision prostheses and also covers fixed andmobile bearing knee designs.

5、1.3 This specification is intended to provide basic descrip-tions of material and prosthesis geometry. Additionally, thosecharacteristics determined to be important to in vivo perfor-mance of the prosthesis are defined. However, compliance withthis specification does not itself define a device that

6、willprovide adequate clinical performance.1.4 Excluded from the scope are hemiarthroplasty devicesthat replace only the femoral or tibial surface, but not both;unicompartmental designs, which replace the articulating sur-faces of only one condyle; and patellofemoral prostheses. Alsoexcluded are devi

7、ces designed for custom applications.1.5 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 SurgicalImplant Applications (UNS R50250, UNS R504

8、00, 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 Me-tallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy fo

9、r 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

10、(UNS S31673)F451 Specification for Acrylic Bone CementF562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applic

11、ations (UNS R30563)3F648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for C

12、ast and Solution-Annealed Surgical Implant ApplicationsF746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for S

13、urgical 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

14、 ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Aug. 15, 2010. Published September 2010. Originallyapproved in 2001. Last previous edition approved in 2008 as F2083 081. DOI:10.1520/F2083

15、-10.2For 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.3Withdrawn. The last approved version of this historical

16、standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Cas

17、tings 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 CoatingsF1223 Test Method for Determinat

18、ion of Total Knee Re-placement ConstraintF1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants(UNS R30075)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F1537 Specification for Wrought Cobalt-2

19、8Chromium-6MolybdenumAlloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF1672 Specification for Resurfacing Patellar ProsthesisF1800 Test Method for Cyclic Fatigue Testin

20、g of MetalTibial Tray Components of Total Knee Joint ReplacementsF1814 Guide for Evaluating Modular Hip and Knee JointComponentsF2384 Specification for Wrought Zirconium-2.5NiobiumAlloy for Surgical Implant Applications (UNS R60901)2.2 ISO Standards:4ISO 6474 Implants for SurgeryCeramic Materials Ba

21、sedon AluminaISO 10993 Biological Evaluation of Medical DevicesISO 142431 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 1: Loading and Displacement Pa-rameters for Wear-Testing Machines with Load Controland Corresponding Environmental Conditions for TestISO 142432 Implants for SurgeryW

22、ear of Total Knee-Joint ProsthesesPart 2: Methods of MeasurementISO 142433 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 3: Loading and Displacement Pa-rameters for Wear-Testing Machines with DisplacementControl and Corresponding Environmental Conditions forTest2.3 FDA Document:US FDA

23、21 CFR 888.6 Degree of Constraint52.4 ANSI/ASME Standard:ANSI/ASME B46.1, Surface Texture (Surface Roughness,Waviness, and Lay)43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 constraint, nthe relative inability of a TKR to befurther displaced in a specific direction under a g

24、iven set ofloading conditions as dictated by the TKRs geometric design.3.1.2 extension, nmotion of the tibia toward bringing itinto axial alignment with the femur.3.1.3 femoral component, nbearing member fixed to thefemur for articulation with the tibial component and thepatellar component or natura

25、l patella.3.1.4 flexion, nmotion of the tibia toward bringing it intocontact with the posterior femoral surface.3.1.5 high flexion, na total knee prosthesis designed tofunction at flexion angles above 125.3.1.6 interlock, nthe mechanical design feature used toincrease capture of one component within

26、 another and torestrict unwanted displacement between components, (that is, acomponent locking mechanism for modular components).3.1.7 patella component, nbearing member fixed to thenatural patella for articulation with the femoral component,which is described in Specification F1672.3.1.8 radiograph

27、ic marker, na nonstructural, generallythin wire, designed to be apparent on X-rays taken afterimplantation for those components that would otherwise benonapparent on such X-rays.3.1.9 tibial component, nbearing member fixed to thetibia for articulation with the femoral component, typicallyeither mon

28、oblock UHMWPE or consisting of two majorcomponents, a metallic tibial tray and a UHMWPE bearingsurface.3.1.10 total knee replacement (TKR), nprosthetic partsthat substitute for the natural opposing tibial, patellar, andfemoral articulating surfaces.4. Classification4.1 The following classification b

29、y degree of constraint issuggested, based on the concepts adopted by the U.S. Food andDrug Administration (see 2.3).4.1.1 ConstrainedA constrained joint prosthesis preventsdislocation of the prosthesis in more than one anatomic planeand consists of either a single, flexible, across-the-joint com-pon

30、ent or more than one component linked together or affined.4.1.2 Semi-constrainedA semi-constrained joint prosthe-sis limits translation or rotation, or both, of the prosthesis inone or more planes via the geometry of its articulating surfaces.It has no across-the-joint linkages.4.1.3 Non-constrained

31、A non-constrained joint prosthesisminimally restricts prosthesis movement in one or more planes.Its components have no across-the-joint linkages.5. Material5.1 The choice of materials is understood to be a necessarybut not sufficient assurance of function of the device madefrom them.All devices conf

32、orming to this specification shall befabricated from materials with adequate mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthSome examples of materialsfrom which total knee replacement components have beensuccessfully fabricated include Specific

33、ations F75, F90, F136,F138, F562, F563, F745, F799, F1108, F1377, F1472, F1537,F1580, and F2384. Polymeric bearing components have been4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from Food and Drug Administ

34、ration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:/www.fda.gov.F2083 102fabricated from UHMWPE as specified in Specification F648.Porous coatings have been fabricated from the materialsspecified in Specifications F67 and F75. Not all of thesematerials may possess sufficient mechanical strengt

35、h for criti-cal highly stressed components nor for articulating surfaces.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use for orthopaedic implant applicationsshall be determined to exhibit corrosion resistance equal to orbetter than one of the materials listed in 5.1.1

36、 when tested inaccordance to Test Method F746. If the corrosion resistance ofa material is less than one of the materials listed in 5.1.1 whentested in accordance with Test Method F746, its use wouldneed to be justified.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful use fo

37、r orthopaedic implant applicationsshall be determined to exhibit acceptable biological responseequal to or better than one of the materials listed in 5.1.1 whentested in accordance with Practices F748, F981,orISO 10993for a given application. If the material is not one of thematerials listed in 5.1.

38、1, then its biocompatibility must beverified in accordance with Practices F748, F981,orISO 10993.6. Performance Requirements6.1 Although the testing methodologies described in thisspecification attempt to identify physiologically relevant testconditions, the interpretation of results is limited to a

39、n in vitrocomparison between knee designs under the stated test condi-tions.6.2 Component FunctionEach component for total kneearthroplasty is expected to function as intended when manu-factured in accordance with good manufacturing practices andto the requirements of this specification. The compone

40、nts shallbe capable of withstanding static and dynamic physiologicloads for the intended use and environment without compro-mise to their function. All components used for experimentalmeasures of performance shall be equivalent to the finishedproduct in form and material. Components shall be sterili

41、zed ifit will affect their performance.NOTE 1Computer models may be used to evaluate many of thefunctional characteristics if appropriate material properties and functionalconstraints are included and the computer models have been validatedwith experimental tests.6.2.1 Individual tibial and femoral

42、components may befatigue tested using relevant test methods under appropriateloading conditions to address loss of supporting foundation.6.2.1.1 Tibial tray components shall be evaluated in accor-dance with Test Method F1800. Each of five specimens shall betested with a maximum load of 900 N (1)6for

43、 10 million cycleswith no failures. All tibial components designated by thisspecification shall pass this minimum requirement.6.2.2 Contact area and contact pressure distributions may bedetermined at various flexion angles using one of severalpublished methods (2-7) to provide a representation of st

44、ressesapplied to the bearing surfaces and to the components. Flexionangles of 0, 15, 30, 60, and 90 are recommended. If theprosthesis is designed to function at higher flexion angles, thenthese measurements should also be made at the maximumflexion angle as determined in 6.2.3. At 90 of flexion and

45、themaximum flexion angle, these measurements should be madeat 0 of rotation and 15 of internal and external rotation. If aninternal or external rotational angle of less than 15 is used, itmust be justified. On mobile bearing systems, contact area andcontact pressure measurements should be made at al

46、l articu-lating surfaces. On mobile bearing systems, to make thesemeasurements at 15 of internal and external rotation, thefemoral component is rotated relative to the tibial base com-ponent and the mobile portion of the articulating component isallowed to come to a static position under load before

47、measurements are taken. If these tests are performed, it isimportant to maintain consistent test parameters and to evalu-ate other TKR prostheses under the same conditions.6.2.3 Range of motion in extension shall be greater than orequal to 0, flexion shall be greater than or equal to 110. Thesemeasu

48、rements apply to components mounted in neutral align-ment in bone or in an anatomically representative substitute. Itis critical to define the location of the neutral alignmentposition, for example, the center of contact areas or patches, interms of dimensions from the outside edges of the component

49、s.The initial positioning or location of the neutral alignmentpoint will alter the range of motion values for certain TKRprostheses.NOTE 2The range of motion of a total knee replacement can bedetermined using the CAD drawings of an implant. The researcher shouldreport how 0 of flexion was defined. Maximum flexion may be defined asthe highest angle at which the following conditions are met: (a) bonyimpingement is not expected; (b) one or both posterior femoral condylesdo not dig (that is, cause polyethylene deformation in the form of an edg