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1.1 This specification covers total ankle replacement (TAR) prostheses used to provide functioning articulation by employing talar and tibial components that allow for a minimum of 15° of dorsiflexion and 15 to 25° (1) of plantar flexion, as determined by non-clinical testing.
1.2 Included within the scope of this specification are ankle components for primary and revision surgery with modular and non-modular designs, bearing components with fixed or mobile bearing designs, and components for cemented and/or cementless use.
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to in vivo performance of the prosthesis are defined.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F451 Specification for Acrylic Bone Cement
F562 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 Implant Applications (UNS R30563)
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy 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 on Muscle and Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
F1223 Test Method for Determination of Total Knee Replacement Constraint
F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
F1580 Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
F1800 Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
F1814 Guide for Evaluating Modular Hip and Knee Joint Components
ICS Number Code 11.180.10 (Aids and adaptations for moving)
UNSPSC Code 42320000(Orthopedic surgical implants)