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ASTM F2068-01

(Specification)

Standard Specification for Femoral Prostheses—Metallic Implants

Standard Specification for Femoral Prostheses—Metallic Implants

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.

General Information

Status
Historical
Publication Date
09-Jul-2001
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F2068-00 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
10-Jul-2001
Replaced By
ASTM F2068-01e1 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
10-Jul-2001
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
10-Jul-2001
Referred By
ASTM G195-22 - Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser
Effective Date
10-Jul-2001

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ASTM F2068-01 - Standard Specification for Femoral Prostheses—Metallic ImplantsASTM F2068-01 - Standard Specification for Femoral Prostheses—Metallic Implants
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ASTM F2068-01 - Standard Specification for Femoral Prostheses—Metallic Implants
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Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 2068 – 01
Standard Specification for
1
Femoral Prostheses—Metallic Implants
This standard is issued under the fixed designation F 2068; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 86 Practice for Surface Preparation and Marking of Me-
2
tallic Surgical Implants
1.1 This specification covers metallic stemmed femoral
F 90 Specification for Wrought Cobalt-20 Chromium-15
prostheses used to replace the natural hip joint by means of
Tungsten-10 Nickel Alloy for Surgical Implant Applica-
hemi-arthroplasty or total hip surgical procedures. Prostheses
2
tions (UNS R30605)
for hemi-arthroplasty are intended to articulate with the natural
F 136 Specification for Wrought Titanium-6 Aluminum-4
acetabulum of the patient. Prostheses for total hip replacement
Vanadium ELI (Extra-Low Interstitial) Alloy (R56401) for
are intended to articulate with prosthetic acetabular cups.
2
Surgical Implant Applications
Prostheses may have integral femoral heads or cones designed
F 138 Specification for Wrought 18 Chromium-14 Nickel-
to accept modular heads.
2.5 Molybdenum Stainless Steel Bar and Wire for Surgical
1.2 Modular femoral heads, which may be affixed to cones
2
Implants (UNS S31673)
on implants covered by this specification, are not covered by
F 562 Specification for Wrought Cobalt-35 Nickel-20
this specification. The mechanical strength, corrosion resis-
Chromium-10 Molybdenum Alloy for Surgical Implant
tance, and biocompatibility of the head portions of one-piece
2
Applications UNS R 30035
integral implants are covered by this specification.
F 563 Specification for Wrought Cobalt-20Nickel-
1.3 Femoral prostheses included within the scope of this
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
specification are intended for fixation by press fit between the
2
for Surgical Implant Applications (UNS R30563)
prosthesis and host bone, the use of bone cement, or through
F 620 Specification for Alpha Plus Beta Titanium Alloy
the ingrowth of host bone into a porous coating.
2
Forgings for Surgical Implants
1.4 Custom femoral prostheses, designed explicitly for a
F 745 Specification for 18Chromium-12.5Nickel-
single patient, are not covered within the scope of this
2.5Molybdenum Stainless Steel for Cast and Solution-
specification.
2
Annealed Surgical Implant Applications
1.5 Prostheses incorporating nonmetallic (for example,
F 746 Test Method for Pitting or Crevice Corrosion of
polymer composite) implants, nonporous bioactive ceramic
2
Metallic Surgical Implant Materials
coatings, or porous-polymer coatings, are specifically excluded
F 748 Practice for Selecting Generic Biological Test Meth-
from the scope of this specification.
2
ods for Materials and Devices
1.6 The requirements for modular connections of multicom-
F 799 Specification for Cobalt-28Chromium-6Molybdenum
ponent modular femoral hip prostheses are not covered by this
Alloy Forgings for Surgical Implants (UNS R31537,
specification.
2
R31538, R31539)
1.7 The values stated in SI units are to be regarded as the
F 981 Practice for Assessment of Compatibility of Bioma-
standard.
terials for Surgical Implants with Respect to Effect of
2
2. Referenced Documents Materials on Muscle and Bone
F 983 Practice for Permanent Marking of Orthopaedic Im-
2.1 ASTM Standards:
2
plant Components
F 67 Specification for Unalloyed Titanium for Surgical
2
F 1044 Test Method for Shear Testing of Calcium Phos-
Implant Applications
2
phate Coatings and Metallic Coatings
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
2
F 1108 Specification for Titanium—6 Aluminum-4 Vana-
Casting Alloy and Cast Products for Surgical Implants
2
dium Alloy Castings for Surgical Implants (UNS R56406)
F 1147 Test Method for Tension Testing of Calcium Phos-
1 2
This specification is under the jurisdiction of ASTM Committee F04 on
phate and Metallic Coatings
Medical and Surgical Materials and Devices and is the direct responsibility of
F 1440 Practice for Cyclic Fatigue Testing of Metallic
Subcommittee F04.22 on Arthroplasty.
Stemmed Hip Arthroplasty Femoral Components Without
Current edition approved July 10, 2001. Published October 2001. Originally
2
published as F 2068 - 00. Last previous edition F 2068 - 00. Torsion
2
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 2068
F 1472 Sp
...

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