ASTM F2068-01e1 - 10.7.2001
 
1. Scope

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 the standard.

 
2. Referenced Documents

F620-20

Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

F562-22

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F2996-20

Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

F1978-22

Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

F1854-15

Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

F1814-22

Standard Guide for Evaluating Modular Hip and Knee Joint Components

F1813-21

Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)

F1586-21

Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)

F1580-18

Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

F1537-20

Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

F1472-23

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1108-21

Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

F1044-05(2017)e1

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).

F983-86(2018)

Standard Practice for Permanent Marking of Orthopaedic Implant Components

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

F799-19

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

F746-04(2021)

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

F86-21

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

F75-23

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F67-13(2017)

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

F138-19

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F136-13(2021)e1

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).

F90-23

Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F1147-05(2017)e1

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).