ASTM F2083-2012 Standard Specification for Knee Replacement Prosthesis《膝关节置换假体的标准规范》.pdf

1、Designation: F2083 11F2083 12Standard Specification forTotal Knee Replacement 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

2、 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 covers total knee replacement (TKR) is intended to cover all the widely used generic types of kneereplacement prostheses u

3、sed to provide functioning articulation by employing femoral and tibial components, allowing a minimumof 110 of flexion to high flexion. articulation. This includes total knee replacement (TKR) and unicondylar knee replacement(UKR) prostheses of both fixed and mobile bearing varieties, and for prima

4、ry or revision surgeries.Although a patellar componentmay be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided inSpecification F1672.1.2 Included within the scope of this specification are replaceable components of modular designs,

5、 for example, tibialarticulating surfaces and all components labeled for, or capable of, being used with cement, regardless of whether the samecomponents can also be used without cement. This includes primary and revision prostheses and also covers fixed and mobilebearing knee designs.1.3 This speci

6、fication is intended to provide basic descriptions of material and prosthesis geometry. Additionally, thosecharacteristics determined to be important to in vivo performance of the prosthesis are defined. However, compliance with thisspecification does not itself define a device that will provide ade

7、quate clinical performance.1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both;unicompartmental designs, which replace the articulating surfaces of only one condyle; and patellofemoral prostheses. Alsoexcluded are devices designed fo

8、r custom applications.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.2. Referenced Documents2.1 ASTM Standards:2F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R505

9、50, UNSR50700)F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical I

10、mplant Applications (UNSR30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical ImplantApplications (UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants(UNS S31673)F4

11、51 Specification for Acrylic Bone CementF562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications(UNS R30035)F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant1 This specification

12、 is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Dec. 1, 2011Nov. 1, 2012. Published December 2011April 2013. Originally approved in 2001. Last previous editi

13、on approved in 20102011 asF2083 10.F2083 11. DOI: 10.1520/F2083-11.10.1520/F2083-12.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary pa

14、ge on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that

15、users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1Applications (UNS R30563)

16、 (Withdrawn 2005)3F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsF732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesF745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast

17、 and Solution-Annealed SurgicalImplant Applications (Withdrawn 2012)3F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF799 Specification for Cobalt-28Chromium-6Molybdenum Alloy

18、 Forgings for Surgical Implants (UNS R31537, R31538,R31539)F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneF983 Practice for Permanent Marking of Orthopaedic Implant ComponentsF1044 Test Method for Shear Testing

19、 of Calcium Phosphate Coatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testing of Calcium

20、 Phosphate and Metallic Medical and Composite CalciumPhosphate/Metallic CoatingsF1223 Test Method for Determination of Total Knee Replacement ConstraintF1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)F1472 Specification for Wrought Titanium

21、-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNSR31538, and UNS R31539)F1580 Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of

22、 Surgical ImplantsF1672 Specification for Resurfacing Patellar ProsthesisF1800 Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsF1814 Guide for Evaluating Modular Hip and Knee Joint ComponentsF2384 Specification for Wrought Zirconium-2.5Niobium Allo

23、y for Surgical Implant Applications (UNS R60901)F2722 Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational StopsF2723 Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic DisassociationF2724 Test Method for Evaluating Mobile Bearing Knee

24、 DislocationF2777 Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion2.2 ISO Standards:4ISO 647416474 Implants for SurgeryCeramic MaterialsPart 1: Ceramic Materials Based on High Purity AluminaISO 10993 Biological Evaluation of Medical DevicesISO 1424

25、31 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 1: Loading and Displacement Parameters forWear-Testing Machines with Load Control and Corresponding Environmental Conditions for TestISO 142432 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 2: Methods of MeasurementISO 1424

26、33 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 3: Loading and Displacement Parameters forWear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test2.3 FDA Document:US FDA 21 CFR 888.6 Degree of Constraint52.4 ANSI/ASME Standard:ANSI/ASME B46.1

27、 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 be further displaced in a specific direction under a given set of loadingconditions as dictated by the TKRs geometric design.

28、3.1.2 extension, nmotion of the tibia toward bringing it into axial alignment with the femur.3.1.3 femoral component, nbearing member fixed to the femur for articulation with the tibial component and the patellarcomponent or natural patella.3.1.4 flexion, nmotion of the tibia toward bringing it into

29、 contact with the posterior femoral surface.3.1.5 high flexion, na total knee prosthesis designed to function at flexion angles above 125.3 The last approved version of this historical standard is referenced on www.astm.org.4 Available from American National Standards Institute (ANSI), 25 W. 43rd St

30、., 4th Floor, New York, NY 10036, http:/www.ansi.org.5 Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http:/www.fda.gov.F2083 1223.1.6 interlock, nthe mechanical design feature used to increase capture of one component within another and to restrictunwanted

31、 displacement between components, (that is, a component locking mechanism for modular components).3.1.7 mobile bearing knee (MBK), na knee replacement system which includes an ultra-high molecular weight polyethylene(UHMWPE) component which, by design, articulates with both the femoral bearing and t

32、he tibial tray.3.1.8 patella component, nbearing member fixed to the natural patella for articulation with the femoral component, which isdescribed in Specification F1672.3.1.9 radiographic marker, na nonstructural, nonstructural radiopaque component, generally thin wire, designed to beapparent on X

33、-rays taken permit radiographic visualization after implantation for those components of components manufacturedof non-radiopaque materials that would otherwise not be nonapparentvisible on such X-rays.radiographs.3.1.10 tibial component, nbearing member fixed to the tibia for articulation with the

34、femoral component, typically eithermonoblock UHMWPE or modular, consisting of two major components, a metallic tibial tray baseplate (tray) and a UHMWPEbearing surface.3.1.10.1 DiscussionModular assemblies may be either fixed or mobile.3.1.11 total knee replacement (TKR), nprosthetic parts that subs

35、titute for the natural opposing tibial, patellar, and femoralarticulating surfaces.3.1.12 unicondylar knee replacement (UKR), nprosthetic parts that substitute for the natural opposing tibial and femoralarticulating surfaces on one condyle.4. Classification4.1 The following classification by degree

36、of constraint is suggested, based on the concepts adopted by the U.S. Food and DrugAdministration (see 2.3).4.1.1 ConstrainedAconstrained joint prosthesis used for joint replacement, and prevents dislocation of the prosthesis in morethan one anatomic plane and consists of either a single, flexible,

37、across-the-joint component or more than one component linkedtogether or affined.4.1.2 Semi-constrainedA semi-constrained joint prosthesis limits translation or rotation, or both, joint prosthesis used forpartial or total joint replacement, and limits translation and rotation of the prosthesis in one

38、 or more planes via the geometry ofits articulating surfaces. It has no across-the-joint linkages.linkage.4.1.3 Non-constrainedA non-constrained joint prosthesis minimally restricts “non-constrained” joint prosthesis is used forpartial or total joint replacement, and restricts minimally prosthesis m

39、ovement in one or more planes. Its components have noacross-the-joint linkages.linkage.5. Material5.1 The choice of materials is understood to be a necessary but not sufficient assurance of function of the device made fromthem. All devices conforming to this specification shall be fabricated from ma

40、terials with adequate mechanical strength anddurability, corrosion resistance, and biocompatibility.5.1.1 Mechanical StrengthVarious components of total Some examples of materials from which knee replacementdevicescomponents have been successfully fabricated from the following materials. See include

41、 Specifications F75, F90, F136,F138, F562, F563, F745, F799, F1108, F1377, F1472, F1537, F1580, F2384,and F2384and ISO 64741. . Polymeric bearingcomponents have been fabricated from UHMWPE as specified in Specification F648. Porous coatings have been fabricated fromthe materials specified in Specifi

42、cations F67 and F75. Not all of these materials may possess sufficient mechanical strength forcritical highly stressed components nor for articulating surfaces.5.1.2 Corrosion ResistanceMaterials with limited or no history of successful use for orthopaedic implant applications shallbe determined to

43、exhibit corrosion resistance equal to or better than one of the materials listed in 5.1.1 when tested in accordanceto Test Method F746. If the corrosion resistance of a material is less than one of the materials listed in 5.1.1 when tested inaccordance with Test Method F746, its use would need to be

44、 justified.5.1.3 BiocompatibilityMaterials with limited or no history of successful use for orthopaedic implant applications shall bedetermined to exhibit acceptable biological response equal to or better than one of the materials listed in 5.1.1 when tested inaccordance with Practices F748, F981, o

45、r ISO 10993 for a given application. If the material is not one of the materials listed in5.1.1, then its biocompatibility mustshall be verified in accordance with Practices F748, F981, or ISO 10993.6. Performance Requirements6.1 Although the testing methodologies described in this specification att

46、empt to identify physiologically relevant testconditions, the interpretation of results is limited to an in vitro comparison between knee designs under the stated test conditions.F2083 1236.2 Component FunctionEach component for total knee arthroplasty is expected to function as intended when manufa

47、cturedin accordance with good manufacturing practices and to the requirements of this specification. The components shall be capableof withstanding static and dynamic physiologic loads for the intended use and environment without compromise to their function.All components used for experimental meas

48、ures of performance shall be equivalent to the finished product in form and material.Components shall be sterilized if it willthis would affect their performance.NOTE 1Computer models may be used to evaluate many of the functional characteristics if appropriate material properties and functional con

49、straintsare included and the computer models have been validated with experimental tests.6.2.1 Individual tibial and femoral components may be fatigue tested baseplates, femoral components, and all-polyethylenetibial components should be fatigue-tested using relevant test methods under appropriate loading conditions to address loss ofsupporting foundation.6.2.1.1 Tibial tray baseplate (tray) components shall be evaluated in accordance with Test Method F1800. Each of fivespecimens shall be tested with and pass for 10 million cycles with no