ASTM F2083-2008e1 Standard Specification for Total Knee Prosthesis.pdf

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1、Designation: F 2083 081Standard 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 i

2、ndicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEEditorial changes were made throughout in December 2008.1. Scope1.1 This specification covers total knee replacement (TKR)prostheses used to provide functioning arti

3、culation by employ-ing femoral and tibial components, allowing 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 wit

4、hin the scope of this specification arereplaceable components 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

5、 prostheses and also covers fixed andmobile bearing knee designs.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 fro

6、m 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 devices designed for custom applications.1.5 The values stated

7、 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 R50400, UNSR50550, UNS R50700)F75 Specification for Cobalt-28

8、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 for Surgical Implant Applica-tions (UNS R30605)F 136 Specifi

9、cation for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401)F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 451 Specification for Acrylic Bone CementF

10、 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications (UNS R30035)F 563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications (UNS R30563)3F 648 Specification for Ultra-Hig

11、h-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 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applica

12、tionsF 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 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F 9

13、81 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 Im-plant Components1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Ma

14、terials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved July 1, 2008. Published August 2008. Originallyapproved in 2001. Last previous edition approved in 2007 as F 2083 07.2For referenced ASTM standards, visit the ASTM website, www.astm.or

15、g, 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 standard is referencedon www.astm.org.1Copyright ASTM International, 10

16、0 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 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 Tens

17、ion Testing of Calcium Phos-phate and Metallic CoatingsF 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 ConstraintF 1377 Specification fo

18、r 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 for Surgical Implants (UNS R31537

19、,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 Components of Total Knee Joint Repla

20、cementsF 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 Standards:4ISO 6474 Implants for SurgeryCeramic Materials Basedon AluminaISO 142432 Implants for SurgeryWear of Tota

21、l 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, Surface Texture (Surface Roughness,Waviness, and Lay)43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 constraint, nthe relativ

22、e 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 component, nbearing member fixed to thefemur f

23、or 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 flexion angles above 125.3.1.6 interlock, n

24、the mechanical design feature used toincrease capture of one component within 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

25、 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 tibial component, nbearing member fixe

26、d 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 natural opposing tibial, patellar, andfem

27、oral 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 the prosthesis in more than one ana

28、tomic planeand consists of either a single, flexible, across-the-joint com-ponent 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 a

29、rticulating surfaces.It has no across-the-joint linkages.4.1.3 Non-constrainedA 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

30、 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 components of totalknee replacemen

31、t 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 inSpecification F 648. Porous

32、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 limited or nohistory of successful

33、 use for orthopaedic implant applicationsshall be determined to exhibit corrosion resistance equal to or4Available 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.F20830812better 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 use for orthopaedic implant applicationsshall be determined to exhibit acceptable b

35、iological responseequal to or better than one of the materials listed in 5.1.1 whentested in 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 intended when manu-factu

36、red in accordance with good manufacturing practices andto the requirements of this specification. The components shallbe capable of withstanding static and dynamic physiologicloads for the intended use and environment without compro-mise to their function. All components used for experimentalmeasure

37、s of performance shall be equivalent to the finishedproduct in form and material. Components shall be sterilized ifit will affect their performance.NOTE 1Computer models may be used to evaluate many of thefunctional characteristics if appropriate material properties and functionalconstraints are inc

38、luded 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 shall be evaluated in a

39、ccor-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 failures. All tibial components designated bythis specification shall pass this minimum requirement.6.1.2 Contact area and contact pressure distributions may bedete

40、rmined 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 flexion angles, thenth

41、ese 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 than 15 is used, itmu

42、st 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 tibial base com-ponent

43、 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 conditions.6.1.3 Range of mot

44、ion in extension shall be greater than orequal to 0, flexion shall be greater than or equal to 110. Thesemeasurements 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

45、example, the center of contact areas or patches, interms of dimensions from the outside edges of the components.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

46、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 i

47、s, cause polyethylene deformation in the form of an edgeor line) into the implant tibial component; or (c) subluxation of one of theposterior femoral condyles or full dislocation does not occur as the kneeis flexed and experiences posterior motion or internal-external rotation ofthe femoral componen

48、t6.1.4 Total knee replacement constraint 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.6.1.5 In order to verify that there

49、is sufficient implantconstraint against subluxation and sufficient laxity (nodigging-in of posterior condyle edges) at maximum flexion (asmeasured in 6.1.3), total knee replacement constraint data forinternal-external rotation and for anterior-posterior motionshould be determined at maximum flexion. At maximumflexion, the device should be able to support anticipatedphysiologic loading conditions and allow internal-externalrotation of 615 without subluxation (8).6.2 All modular components shall be evaluated for theintegrity of their connect