1、Designation: F 2083 08Standard 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 () 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
3、 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 desig
5、ns.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
6、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 in SI units are to be regarded asstandard. No other units of
7、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 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surg
8、ical 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 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low
9、 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 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10
10、Molybdenum 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-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form fo
11、r 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 ApplicationsF 746 Test Method for Pitting or Crevice Corrosion ofMeta
12、llic 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 981 Practice for Assessment of Compatibility of Bioma-terials f
13、or Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic CoatingsF 1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Casting
14、s for Surgical Implants (UNS R56406)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 July 1, 2008. Published August 2008. Originallyapproved
15、 in 2001. Last previous edition approved in 2007 as F 2083 07.2For 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
16、.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF 1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic M
17、edical and Compos-ite Calcium Phosphate/Metallic CoatingsF 1223 Test Method for Determination of Total Knee Re-placement ConstraintF 1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants(UNS R30075)F 1472 Specification for Wrought Titanium-6Aluminum-4Vanadium
18、 Alloy for Surgical Implant Applications (UNSR56400)F 1537 Specification for Wrought Cobalt-28Chromium-6MolybdenumAlloys 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 16
19、72 Specification for Resurfacing Patellar ProsthesisF 1800 Test Method for Cyclic Fatigue Testing of MetalTibial Tray Components of Total Knee Joint ReplacementsF 1814 Guide for Evaluating Modular Hip and Knee JointComponentsF 2384 Specification for Wrought Zirconium-2.5NiobiumAlloy for Surgical Imp
20、lant Applications (UNS R60901)2.2 ISO Standard:4ISO 6474 Implants for SurgeryCeramic Materials Basedon AluminaISO 142432 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
21、.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 given set ofloading conditions as dictated by the TKRs geometric design
22、.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 natural patella.3.1.4 flexion, nmotion of the tibia toward bringing it intoc
23、ontact 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 another and torestrict unwanted displacement between components, that
24、 is,component 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 F 1672.3.1.8 radiographic marker, na nonstructural, generallythin wire, designed to be apparent
25、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 monoblock UHMWPE or consisting of two majorcomponents, a metallic tibial tra
26、y 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 by degree of constraint issuggested based on the concepts adopted by the U
27、.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-ponent or more than one component linked together or affined.4.1.2 Semi-const
28、rainedA 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-constrainedA non-constrained joint prosthesisminimally restricts prosthesis movement
29、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 conforming to this specification shall befabricated from materials with adequa
30、te mechanical strengthand durability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components 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
31、 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 coatings have been fabricated fromthe materials specified in Specifications F67and F75. Not allof these materials may possess sufficient mechanical stre
32、ngthfor critical highly stressed components nor for articulatingsurfaces.5.1.2 Corrosion ResistanceMaterials with limited 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 w
33、hen tested inaccordance to Test Method F 746.5.1.3 BiocompatibilityMaterials with limited or no his-tory of successful use for orthopaedic implant application mustbe determined to exhibit acceptable biological response equal4Available from American National Standards Institute (ANSI), 25 W. 43rd St.
34、,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:/www.fda.gov.F2083082to 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
35、.6. Performance Requirements6.1 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 components shallbe capable of withstanding static and d
36、ynamic physiologicloads without compromise to their function for the intended useand environment. All components used for 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 1Com
37、puter 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.6.1.1 Individual tibial and femoral components may befatigue tested using relevant t
38、est methods under appropriateloading conditions to address loss of supporting foundation.6.1.1.1 Tibial tray components 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 c
39、omponents designated by thisspecification shall pass this minimum requirement.6.1.2 Contact area and contact pressure distributions may bedetermined at various flexion angles using one of severalpublished methods (2-7) to provide a representation of stressesapplied to the bearing surfaces and to the
40、 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 6.1.3. At 90 of flexion and themaximum flexion angle, these measurements sho
41、uld 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 all articu-lating surfaces. On mobile bearing syst
42、ems, 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 beforemeasurements are taken. If these tests are perfo
43、rmed, it isimportant to maintain consistent test parameters and to evalu-ate other TKR prostheses under the same conditions.6.1.3 Flexion shall range from a minimum of 0 to amaximum of 110 or more. These measurements apply tocomponents mounted in neutral alignment in bone or in ananatomically repres
44、entative substitute. It is critical to define thelocation of the neutral alignment position, for example, centerof contact areas or patches, in terms of dimensions fromoutside edges of the components. The initial positioning orlocation of the neutral alignment point will affect the range ofmotion va
45、lues for certain TKR prostheses.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 has beenexceeded if: (a) bony impingement occurs; (b) one or both posteriorfemoral co
46、ndyles do not dig (that is, cause polyethylene deformation inthe form of an edge or line) into the implant tibial component; or (c)subluxation of one or the posterior femoral condyles or full dislocationdoes not occur as the knee is flexed and simultaneous posterior motion orinternal-external rotati
47、on of the femoral component.6.1.4 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
48、order to verify that there 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 det
49、ermined 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 must be evaluated for theintegrity of their connecting 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 anticipate
