ASTM F2068-15
Standard Specification for Femoral Prostheses—Metallic Implants

Standard No.

ASTM F2068-15

Release Date

2015

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2068-15

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 standard. No other units of measurement are included in this standard.

ASTM F2068-15 Referenced Document

• ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
• ASTM F1108 Standard Specification for Ti6Al4V Alloy Castings for Surgical Implants (UNS R56406)
• ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
• ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
• ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
• ASTM F1472 Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
• ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM F1580 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
• ASTM F1586 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium8212;10 Nickel8212;3 Manganese8212;2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
• ASTM F1813 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
• ASTM F1814 Standard Guide for Evaluating Modular Hip and Knee Joint Components
• ASTM F1854 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
• ASTM F1978 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber^TM Abraser
• ASTM F2996 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
• ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
• ASTM F620 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• ASTM F746 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• ASTM F799 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
• ASTM F983 Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ISO 7206-7 Implants for surgery — Partial and total hip joint prostheses — Part 7: Endurance performance of stemmed femoral components without application of torsion

ASTM F2068-15 history

• 2015 ASTM F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants
• 2009 ASTM F2068-09 Standard Specification for Femoral Prostheses8212;Metallic Implants
• 2003 ASTM F2068-03 Standard Specification for Femoral Prostheses8212;Metallic Implants
• 2001 ASTM F2068-01e1 Standard Specification for Femoral Prostheses8212;Metallic Implants
• 2001 ASTM F2068-01 Standard Specification for Femoral Prostheses8212;Metallic Implants
• 2000 ASTM F2068-00 Standard Specification for Femoral Prostheses8212;Metallic Implants