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This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads. Femoral prostheses presented are defined as follows: type IA - single-piece (mono-block), metallic femoral total hip or hemi-arthroplasty hip prosthesis with an integral stem, neck and head, type IB - single-piece (mono-block), metallic, femoral total hip or hemi- arthroplasty hip prostheses with an integral stem, neck, and head, type IIA - modular metallic femoral hip prostheses that could include a modular (type II) head or other modular components, or both, and type IIB - Modular metallic femoral hip prosthesis that could include a modular (type II) head or other modular components, or both. Femoral prostheses shall be capable of withstanding normal static and dynamic loading in the physiological range without overload fracture, plastic deformation, or fatigue fracture. Shear strength, tensile strength, and abrasion resistance of plasma spray thermal coatings shall be tested to meet the requirements prescribed.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads.
1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.
1.3 Femoral prostheses included within the scope of this specification are intended for fixation by press fit between the prosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating.
1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.
1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification.
1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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)
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)
F620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
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
F1440 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
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
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium--10Nickel--3Manganese--2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
F1612 Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion
F1636 Specification for Bores and Cones for Modular Femoral Heads
F1813 Specification for Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120)
F1814 Guide for Evaluating Modular Hip and Knee Joint Components
F1854 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F1978 Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
ISO DocumentsISO7206-6:1992 Implants for SurgeryPartial and Total Hip Joint ProsthesesPart 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)