ASTM F2083-2007 Standard Specification for Total Knee Prosthesis《全膝盖假肢的标准规范》.pdf

1、Designation: F 2083 07Standard Specification forTotal Knee Prosthesis1This standard is issued under the fixed designation F 2083; 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 in

2、dicates the year of last reapproval. Asuperscript epsilon (e) 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, allowin

3、g a 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 F 1672.1.2 Included within the scope of this specification arereplaceable components

4、 of 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 design

5、s.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.1.4 Excluded from the scope are hemiarthroplasty devicesthat replace only the f

6、emoral or tibial surface, but not both;unicompartmental designs, which replace the articulating sur-faces of only one condyle; and patellofemoral prostheses. Alsoexcluded are devices designed for custom applications.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium,

7、 for SurgicalImplant 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 Me-tallic Surgical ImplantsF90 Specification for

8、 Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Moly

9、bdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 451 Specification for Acrylic Bone CementF 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5M

10、olybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF 745 Specificatio

11、n for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsF 746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 799 S

12、pecification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 983 Practice for Permanent Marking of Orthopaedic

13、 Im-plant ComponentsF 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic CoatingsF 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F 1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic Coatings1This s

14、pecification 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 Aug. 1, 2007. Published September 2007. Originallyapproved in 2001. Last previous edition approved

15、 in 2006 as F 2083 06b.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.1Copyright ASTM Internation

16、al, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF 1223 Test Method for Determination of Total Knee Re-placement

17、ConstraintF 1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants(UNS R30075)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F 1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys

18、for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539)F 1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadium Alloy Powders for Coatings ofSurgical ImplantsF 1672 Specification for Resurfacing Patellar ProsthesisF 1800 Test Method for Cyclic Fatigue Testing of MetalTibial Tray Com

19、ponents of Total Knee Joint ReplacementsF 1814 Guide for Evaluating Modular Hip and Knee JointComponentsF 2384 Specification for Wrought Zirconium-2.5NiobiumAlloy for Surgical Implant Applications (UNS R60901)2.2 ISO Standard:4ISO 6474 Implants for SurgeryCeramic Materials Basedon AluminaISO 142432

20、Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 2: Methods of Measurement2.3 FDA Document:US FDA 21 CFR 888.6 Degree of Constraint52.4 ANSI/ASME Standard:ANSI/ASME B46.1-1995, Surface Texture (Surface Rough-ness, Waviness, and Lay)43. Terminology3.1 Definitions of Terms Specific to This

21、Standard:3.1.1 constraint, nthe relative inability of a TKR to befurther displaced in a specific direction under a given 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 compone

22、nt, nbearing member fixed to thefemur for articulation with the tibial component and thepatellar component or natural 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 flex

23、ion angles above 125.3.1.6 interlock, nthe mechanical design feature used toincrease capture of one component within another and torestrict unwanted displacement between components, that is,component locking mechanism for modular components.3.1.7 patella component, nbearing member fixed to thenatura

24、l patella for articulation with the femoral component,which is described in Specification F 1672.3.1.8 radiographic 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 tib

25、ial component, nbearing member fixed to thetibia for articulation with the femoral component, typicallyeither monoblock 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 natura

26、l opposing tibial, patellar, andfemoral articulating surfaces.4. Classification4.1 The following classification by 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 t

27、he prosthesis in more than one anatomic planeand consists of either a single, flexible, across-the-joint com-ponent or more than one component linked together or affined.4.1.2 SemiconstrainedA semiconstrained joint prosthesislimits translation or rotation, or both, of the prosthesis in one ormore pl

28、anes via the geometry of its articulating surfaces. It hasno across-the-joint linkages.4.1.3 NonconstrainedA nonconstrained 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 underst

29、ood to be a necessarybut not sufficient assurance of function of the device madefrom them.All devices conforming to this specification shall befabricated from materials with adequate mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious compon

30、ents of totalknee replacement devices have been successfully fabricatedfrom the following materials. See Specifications F75, F90,F 136, F 138, F 562, F 563, F 745, F 799, F 1108, F 1377,F 1472, F 1537, F 1580, and F 2384. Polymeric bearing com-ponents have been fabricated from UHMWPE as specified in

31、Specification F 648. Porous coatings have been fabricated fromthe materials specified in Specifications F67and F75. Not allof these materials may possess sufficient mechanical strengthfor critical highly stressed components nor for articulatingsurfaces.5.1.2 Corrosion ResistanceMaterials with limite

32、d or nohistory of successful use for orthopaedic implant applicationmust be determined to exhibit corrosion resistance equal to orbetter than one of the materials listed in 5.1.1 when tested inaccordance to Test Method F 746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful u

33、se for orthopaedic implant application mustbe determined to exhibit acceptable biological response equal4Available 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 Administration (FDA), 5600 Fishers Ln.,

34、Rockville, MD 20857, http:/www.fda.gov.F2083072to or better than one of the materials listed in 5.1.1 when testedin accordance with Practices F 748 and F 981 for a givenapplication.6. Performance Requirements6.1 Component FunctionEach component for total kneearthroplasty is expected to function as i

35、ntended when manu-factured in accordance with good manufacturing practices andto the requirements of this specification. The components shallbe capable of withstanding static and dynamic physiologicloads without compromise to their function for the intended useand environment. All components used fo

36、r experimental mea-sures of performance shall be equivalent to the finished productin form and material. Components shall be sterilized if it willaffect their performance.NOTE 1Computer models may be used to evaluate many of thefunctional characteristics if appropriate material properties and functi

37、onalconstraints are included and the computer models have been validatedwith experimental tests.6.1.1 Individual tibial and femoral components may befatigue tested using relevant test methods under appropriateloading conditions to address loss of supporting foundation.6.1.1.1 Tibial tray components

38、shall be evaluated in accor-dance with Test Method F 1800. Each of five specimens shallbe tested with a maximum load of 900 N (1)6for 10 millioncycles with no failure. All tibial components designated by thisspecification shall pass this minimum requirement.6.1.2 Contact area and contact pressure di

39、stributions may bedetermined at various flexion angles using one of severalpublished methods (2-7) to provide a representation of stressesapplied 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

40、flexion angles, thenthese measurements should also be made at the maximumflexion angle as determined in 6.1.3. At 90 of flexion and 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

41、 than 15 is used, itmust be justified. On mobile bearing systems, contact area andcontact pressure measurements should be made at all articu-lating surfaces. On mobile bearing systems, to make thesemeasurements at 15 of internal and external rotation, thefemoral component is rotated relative to the

42、tibial base com-ponent and the mobile portion of the articulating component isallowed to come to a static position under load beforemeasurements are taken. If these tests are performed, it isimportant to maintain consistent test parameters and to evalu-ate other TKR prostheses under the same conditi

43、ons.6.1.3 Range of motion in flexion/extension shall be greaterthan or equal to 0, flexion shall be greater than or equal to110. These measurements apply to components mounted inneutral alignment in bone or in an anatomically representativesubstitute. It is critical to define the location of the neu

44、tralalignment position, for example, center of contact areas orpatches, in terms of dimensions from outside edges of thecomponents. The initial positioning or location of the neutralalignment point will affect the range of motion values forcertain TKR prostheses.6.1.4 Total knee replacement constrai

45、nt data for internal-external rotation, anterior-posterior displacement, and medial-lateral displacement may be determined in accordance withTest Method F 1223. Testing implants at 0, 15, 90, andmaximum flexion is recommended.6.2 All modular components must be evaluated for theintegrity of their con

46、necting mechanisms. As suggested inGuide F 1814, static and dynamic shear tests, bending tests,and tensile tests or any combination may be necessary todetermine the performance characteristics. The connectionmechanisms must show sufficient integrity for the range ofloads anticipated for the applicat

47、ion.6.3 It is important to understand the wear performance forarticulating surfaces. Any new or different material couplemust not exceed the wear rates of the following material couplewhen tested under physiological conditions. The current stan-dard wear couple is CoCrMo alloy (see Specification F75

48、)against UHMWPE (see Specification F 648) both havingprosthetic-quality surface finishes as described in 8.2 and 8.3.6.3.1 Materials may be tested in a pin-on-flat or pin-on-disktest apparatus such as described in Test Method F 732 withadequate controls for comparison. A number of different loadleve

49、ls may be used to cover the range of anticipated stressesbetween articulating components.NOTE 2In situations in which the pin-on-flat test may not be consid-ered appropriate, other tests may be considered, that is, knee simulationmodes of prosthesis wear performance testing or those described inISO 6474 or other published documents.6.3.2 Functional wear tests also may be performed toevaluate material and design performance. Since it is unlikelythat one set of test conditions can simulate all aspects of kneefunction, it is recommended that various