ASTM F2665-2009(2014) Standard Specification for Total Ankle Replacement Prosthesis《全踝关节置换假体的标准规格》.pdf

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1、Designation: F2665 09 (Reapproved 2014)Standard Specification forTotal Ankle Replacement Prosthesis1This standard is issued under the fixed designation F2665; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisio

2、n. A number 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 ankle replacement (TAR)prostheses used to provide functioning articulation by employ-ing talar and

3、 tibial components that allow for a minimum of15 of dorsiflexion and 15 to 25 (1)2of plantar flexion, asdetermined by non-clinical testing.1.2 Included within the scope of this specification are anklecomponents for primary and revision surgery with modular andnon-modular designs, bearing components

4、with fixed or mobilebearing designs, and components for cemented and/or cement-less use.1.3 This specification is intended to provide basic descrip-tions of material and prosthesis geometry. In addition, thosecharacteristics determined to be important to in vivo perfor-mance of the prosthesis are de

5、fined.1.4 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establis

6、h appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3F67 Specification for Unalloyed Titanium, for Surgical Im-plant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700)F75 Specification

7、for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605

8、)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 (UNS S31673)F451 Specification for Acrylic Bo

9、ne 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 Applications (UNS R30563) (With-drawn 2005)4F565 Pr

10、actice for Care and Handling of Orthopedic Implantsand InstrumentsF648 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-

11、12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn2012)4F746 Test Method for Pitting or Crevice Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Specif

12、ication for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical 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 Bone1This specification is under the jurisdiction of ASTM Com

13、mittee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved July 15, 2014. Published September 2014. Originallyapproved in 2009. Last previous edition approved in 2009 as F2665 - 09. DOI:10.1520/F2665-09R14.2

14、The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3For 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

15、Summary page onthe ASTM website.4The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1F983 Practice for Permanent Marking of Orthopaedic Im-plant Components

16、F1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Castings for Surgical Implants (UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1160 Test Method for Shear and

17、Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic CoatingsF1223 Test Method for Determination of Total Knee Re-placement ConstraintF1377 Specification for Cobalt-28Chromium-6MolybdenumPowder for Coating of Orthopedic Implants (UNSR30075)F1472

18、Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNSR56400)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNSR31537, UNS R31538, and UNS R31539)F1580 Specification for Titanium and Titanium-6Aluminum-4 Vanadi

19、um Alloy Powders for Coatings ofSurgical ImplantsF1800 Practice for Cyclic Fatigue Testing of Metal TibialTray Components of Total Knee Joint ReplacementsF1814 Guide for Evaluating Modular Hip and Knee JointComponents2.2 ISO Standards:5ISO 6474 Implants for SurgeryCeramic Materials Basedon AluminaIS

20、O 142432 Implants for SurgeryWear of Total Knee-Joint ProsthesesPart 2: Methods of Measurement2.3 FDA Document:621 CFR 888.6 Degree of Constraint21 CFR 888.3110 Ankle Joint Metal/Polymer Semi-Constrained Cemented Prostheses21 CFR 888.3120 Ankle Joint Metal/Polymer Non-Constrained Cemented Prostheses

21、2.4 ANSI/ASME Standard:5ANSI/ASME B46.11995 Surface Texture (SurfaceRoughness, Waviness, and Lay)3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 constraint, nthe relative inability of a TAR, inherentto its geometrical and material design, to be further displacedin a specific d

22、irection under a given set of loading conditions.3.1.2 dorsiflexion, nrotation of the tibial component to-wards the anterior talar surface.3.1.3 flexion, nrotation of the talar component relative tothe tibial component around the medial-lateral axis. Flexion isconsidered positive when it is dorsifle

23、xion, and negative whenit is plantar flexion.3.1.4 interlock, nmechanical design feature used to in-crease capture of one component within another and to restrictunwanted displacement between components, that is, compo-nent locking mechanism for modular components.3.1.5 plantar flexion, nrotation of

24、 the tibial componenttoward the posterior talar surface.3.1.6 talar component, nbearing member fixed to thetalus for articulation with the tibial component. This could bemetallic or from some other suitably hard surface material.3.1.7 radiographic marker, na nonstructural wire or beaddesigned to be

25、apparent on X-rays taken after implantation forthose components that would otherwise not be apparent onsuch X-rays.3.1.8 subluxation, ninstability or partial dislocationwhich occurs when the relative translational or rotationalmotion between the talar and tibial components reaches anextreme where th

26、e two components would cease to articulateover the designated low friction bearing surfaces.3.1.9 tibial component, nfixed or mobile bearing memberattached to the tibia for articulation with the talar component,typically consisting of two major components, a metallic tibialtray and an ultra-high-mol

27、ecular-weight (UHMWPE) (seeSpecification F648) bearing surface.3.1.10 total ankle replacement (TAR), n prosthetic partsthat substitute for the natural opposing tibial and talar articu-lating surfaces.3.1.11 IE rotation, nrotation of the tibial componentrelative to the talar component around the tibi

28、al axis. IErotation is considered positive when the tibial componentrotates internally (clockwise when viewed proximally on theleft ankle). IE rotation is considered negative when the tibialcomponent rotates externally.4. Classification4.1 The following classification by degree of constraint issugge

29、sted for all total joint prostheses including total anklereplacement systems based on the concepts adopted by the U.S.Food and Drug Administration (see 21 CFR 888.6).4.1.1 ConstrainedA constrained joint prosthesis preventsdislocation of the prosthesis in more than one anatomic planeand consists of e

30、ither a single, flexible, across the-jointcomponent or more than one component linked together oraffined.4.1.2 Semi-constrainedA semi-constrained joint prosthe-sis limits translation or rotation, or both translation and rotationof the prosthesis in one or more planes via the geometry of itsarticulat

31、ing surfaces. Its components have no across-the-jointlinkages.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.5Available from American National Standards Institute (ANSI), 25 W. 43rd

32、 St.,4th Floor, New York, NY 10036, http:/www.ansi.org.6Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, http:/www.fda.gov.F2665 09 (2014)24.2 Currently, most ankle designs are considered eithersemi-constrained or non-constrained. Most mobile bearingankle comp

33、onents are considered non-constrained. The USgovernment 21 CFR 888.3110 identifies ankle joint metal/polymer semi-constrained cemented prosthesis and21 CFR 888.3120 identifies ankle joint metal/polymer non-constrained cemented prosthesis.5. Material5.1 All devices conforming to this specification sh

34、all befabricated from materials with adequate mechanical strength,durability, corrosion resistance, and biocompatibility.NOTE 1The choice of materials is understood to be a necessary butnot totally sufficient assurance of proper function of the device made fromthem.5.1.1 Mechanical StrengthVarious m

35、etallic componentsof total ankle replacement devices have been successfullyfabricated from materials, as examples, found in SpecificationsF75, F90, F136, F138, F562, F563, F745, F799, F1108, F1377,F1472, F1537, and F1580. Polymeric bearing componentshave been fabricated from UHMWPE, as an example, a

36、sspecified in Specification F648. Porous coatings have beenfabricated from example materials specified in SpecificationsF67 and F75. Not all of these materials may possess sufficientmechanical strength for critical, highly stressed components orfor articulating surfaces. Conformance of a selected ma

37、terial toits standard and successful clinical usage of the material in aprevious implant design are not sufficient to ensure the strengthof an implant. Manufacturing processes and implant design canstrongly influence the devices performance characteristics.Therefore, regardless of the material selec

38、ted, the ankle im-plant must meet the performance requirements of Section 6.5.1.2 Corrosion ResistanceMaterials with limited or nohistory of successful use for orthopaedic implant applicationshall exhibit corrosion resistance equal to or better than one ofthe materials listed in 5.1.1 when tested in

39、 accordance withTest Method F746.5.1.3 BiocompatibilityMaterials with limited or no historyof successful use for orthopaedic implant application shallexhibit acceptable biological response equal to or better thanone of the materials listed in 5.1.1 when tested in accordancewith Practices F748 and F9

40、81 for a given application.6. Performance Requirements6.1 Component FunctionEach component for total anklearthroplasty 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 o

41、f withstanding static and dynamic physiologicloads (1) without compromising their function for the intendeduse and environment. All components used for experimentalmeasures of performance shall be equivalent to the finishedproduct in form and material. Components shall be sterilized ifthe sterilizat

42、ion process will affect their performance.NOTE 2Computer 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 (that is,

43、 tibial tray and bearing surfacecomponents) and talar components should be fatigue testedusing relevant or analogous test methods under appropriateloading conditions (including worst-case scenarios) to addressloss of supporting foundation leading to potential deformationand/or component fracture.6.1

44、.1.1 Tibial tray components may be evaluated in amanner similar to Test Method F1800, with a loading momentvalue chosen to compare with a clinically successful implant,or justified in other suitable ways for the design being tested)(2). In choosing the loading moment, both the moment arm andthe load

45、 used shall be specified with explanation as to how andwhy they were chosen. Each of five specimens shall be testedfor 10 million cycles with no failure. All tibial componentsdesignated by this specification shall pass this minimumrequirement.6.1.1.2 Tibial bearing surface components shall be fatigu

46、etested considering worst-case scenarios to demonstrate that thecomponent is able to withstand anticipated physiologicalloading conditions and is not susceptible to the failure modesthat have been reported in the literature (3-5). The worst-casescenarios should take into consideration loads, compone

47、ntsizes, thickness of the plastic bearing insert, bony support,locking mechanism, edge loading, misalignments and howthese can affect the individual design.6.1.2 Contact area and contact pressure distributions may bedetermined at various flexion angles using one of severalpublished methods (6-11) to

48、 provide a representation ofstresses applied to the bearing surfaces and to the components.Flexion angles of 0, 610, and 615 are recommended. If theprosthesis is designed to function at higher angles of dorsiflex-ion or plantar flexion, then it is recommended that thesemeasurements be continued at 5

49、 increments to the full rangeof motion. If these tests are performed, it is important tomaintain consistent test parameters and to evaluate other TARprostheses under the same conditions.6.1.3 Range of motion in dorsiflexion and plantar flexionshall be greater than or equal to 15 (each) which is requiredfor walking (12-14). These measurements apply to componentsmounted in neutral alignment in bone or in an anatomicallyrepresentative substitute. It is critical to define the location ofthe neutral alignment position, for example, center of contactareas or