Designation: F2091 − 15

Standard Specification for

Acetabular Prostheses1
This standard is issued under the fixed designation F2091; 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 (´) indicates an editorial change since the last revision or reapproval.

1. Scope F90 Specification for Wrought Cobalt-20Chromium-

1.1 This specification covers acetabular resurfacing devices 15Tungsten-10Nickel Alloy for Surgical Implant Applica-
used to provide a functioning articulation between the bones of tions (UNS R30605)
the acetabulum and the femur. F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
1.2 This specification is intended to provide basic descrip- Implant Applications (UNS R56401)
tions of materials and device geometry. Additionally, those F138 Specification for Wrought 18Chromium-14Nickel-
characteristics determined to be important to in vivo perfor- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
mance of the device are defined. Implants (UNS S31673)
1.3 Acetabular prostheses included within the scope of this F562 Specification for Wrought 35Cobalt-35Nickel-
specification are intended for fixation by press-fit between the 20Chromium-10Molybdenum Alloy for Surgical Implant
prosthesis and host bone, the use of bone cement, the use of Applications (UNS R30035)
bone screws or similar means of mechanical fixation, or F601 Practice for Fluorescent Penetrant Inspection of Me-
through biological fixation of host bone and/or soft connective tallic Surgical Implants
tissue into a porous surface. F603 Specification for High-Purity Dense Aluminum Oxide
1.4 Custom (designed explicitly for a single patient), for Medical Application
revision, or constrained acetabular prostheses are not covered F629 Practice for Radiography of Cast Metallic Surgical
within the scope of this specification. Implants
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.5 This specification does not cover the details for quality ethylene Powder and Fabricated Form for Surgical Im-
assurance, design control, production control contained in 21 plants
CFR 820 (Quality System Regulation) and ISO 9001. F746 Test Method for Pitting or Crevice Corrosion of
2. Referenced Documents Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods
2.1 ASTM Standards:2 for Materials and Devices
F67 Specification for Unalloyed Titanium, for Surgical Im- F799 Specification for Cobalt-28Chromium-6Molybdenum
plant Applications (UNS R50250, UNS R50400, UNS Alloy Forgings for Surgical Implants (UNS R31537,
R50550, UNS R50700) R31538, R31539)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum F981 Practice for Assessment of Compatibility of Biomate-
Alloy Castings and Casting Alloy for Surgical Implants rials for Surgical Implants with Respect to Effect of
(UNS R30075) Materials on Muscle and Bone
F86 Practice for Surface Preparation and Marking of Metal- F983 Practice for Permanent Marking of Orthopaedic Im-
lic Surgical Implants plant Components
F1044 Test Method for Shear Testing of Calcium Phosphate
1
This specification is under the jurisdiction of ASTM Committee F04 on Coatings and Metallic Coatings
Medical and Surgical Materials and Devices and is the direct responsibility of F1108 Specification for Titanium-6Aluminum-4Vanadium
Subcommittee F04.22 on Arthroplasty.
Current edition approved March 15, 2015. Published May 2015. Originally Alloy Castings for Surgical Implants (UNS R56406)
approved in 2001. Last previous edition approved in 2012 as F2091 – 01 (2012). F1147 Test Method for Tension Testing of Calcium Phos-
DOI: 10.1520/F2091-15.
2
phate and Metallic Coatings
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM
F1160 Test Method for Shear and Bending Fatigue Testing
Standards volume information, refer to the standard’s Document Summary page on of Calcium Phosphate and Metallic Medical and Compos-
the ASTM website. ite Calcium Phosphate/Metallic Coatings

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States

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 F2091 − 15
F1185 Specification for Composition of Hydroxylapatite for 2.3 Code of Federal Regulations:
Surgical Implants 21 CFR 820 Quality System Regulation4
F1377 Specification for Cobalt-28Chromium-6Molybdenum
3. Terminology
Powder for Coating of Orthopedic Implants (UNS
R30075) 3.1 Definitions:
F1472 Specification for Wrought Titanium-6Aluminum- 3.1.1 bearing element, n—articulating surface element be-
4Vanadium Alloy for Surgical Implant Applications (UNS tween the femoral head and shell or bonding agent (bone
R56400) cement).
F1537 Specification for Wrought Cobalt-28Chromium- 3.1.2 cavity, n—any slot, cut, hole, or other feature within
6Molybdenum Alloys for Surgical Implants (UNS the shell intended to accommodate modular adjunct fixation
R31537, UNS R31538, and UNS R31539) elements; instruments for insertion, extraction, and so forth; or
F1580 Specification for Titanium and Titanium-6 for manufacturing purposes.
Aluminum-4 Vanadium Alloy Powders for Coatings of 3.1.3 fixation element, n—any peg, spike, threadform, or
Surgical Implants other protrusion from the exterior surface of the shell intended
F1714 Guide for Gravimetric Wear Assessment of Prosthetic to increase the surface contact or mechanical interlock between
Hip Designs in Simulator Devices the component, the bonding agent, the natural acetabulum, or a
F1820 Test Method for Determining the Forces for Disas- combination thereof.
sembly of Modular Acetabular Devices
F1978 Test Method for Measuring Abrasion Resistance of 3.1.4 flange, n—rim extending from the entry diameter of
Metallic Thermal Spray Coatings by Using the Taber bearing element.
Abraser 3.1.5 porous surface, n—a region on the exterior surface of
F2033 Specification for Total Hip Joint Prosthesis and Hip the shell characterized by interconnecting subsurface pores,
Endoprosthesis Bearing Surfaces Made of Metallic, generally with volume porosity between 30 and 70 %, average
Ceramic, and Polymeric Materials pore size between 100 and 1000 µm, and a thickness between
F2565 Guide for Extensively Irradiation-Crosslinked Ultra- 500 and 1500 µm. This porous layer may be manufactured
High Molecular Weight Polyethylene Fabricated Forms directly into the device by casting or by various electro/
for Surgical Implant Applications chemical/thermal/mechanical means, or applied as a coating of
F2582 Test Method for Impingement of Acetabular Prosthe- particles, beads, or mesh by processes such as sintering or
ses plasma spray.
2.2 ISO Standards: 3.1.6 radiographic marker, n—nonstructural, generally thin
ISO 5832-1, -3, -4, -9, -12, -12/Cor:1, -14 Implants for wire, designed to be apparent on X-rays taken after placement
surgery—Metallic materials for surgical implants3 of implants that otherwise would be unapparent on such
ISO 5834-1, -2, -3, -4, -5 Implants for surgery—Ultra high X-rays.
molecular weight polyethylene3 3.1.7 retention element, n—any ring, taper, wire, or other
ISO 6474-1 Implants for surgery—Ceramic materials based protrusion or cavity from the interior surface of the shell or the
on high purity alumina3 exterior surface of the bearing element that is intended to affix
ISO 6474-2 Implants for surgery—Ceramic materials—Part the bearing element to the shell.
2: Composite materials based on a high-purity alumina
3.1.8 shell, n—metal structure supporting the articulating
matrix with zirconia reinforcement3
surface material, and which may be fixed rigidly to the
ISO 9001 Quality systems—Model for quality assurance in
articulating surface or fixed such that it allows the articulating
design/development, production, installation, and servic-
surface to rotate or translate.
ing3
ISO 14242-1 Implants for surgery—Wear of total hip-joint 3.1.9 surface texturing, n—repetitive or random deviations
prostheses—Part 1: Loading and displacement parameters from the nominal surface that forms the three dimensional
for wear-testing machines and corresponding environmen- topography of the surface.
tal conditions for test3 3.2 Dimensions of acetabular prostheses should be desig-
ISO 14242-2 Implants for surgery—Wear of total hip-joint nated in accordance with Figs. 1-3 or by an equally acceptable
prostheses—Part 2: Methods of measurement3 and detailed method.
ISO 14242-3 Implants for surgery—Wear of total hip joint
NOTE 1—Figs. 1-3 are intended to be illustrative of typical acetabular
prostheses—Part 3: Loading and displacement parameters prostheses and to designate dimensions, but representation of the compo-
for orbital bearing type wear testing machines and corre- nents does not otherwise form part of the standard.
sponding environmental conditions for test3
ISO 21535 Non-active surgical implants—Joint replacement 4. Types
implants—Specific requirements for hip-joint replacement 4.1 Acetabular prostheses falling within the scope of this
implant3 specification are of two types, as defined below. There are no

4
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
3
Available from International Organization for Standardization (ISO), 1, ch. de Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://
la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org. dodssp.daps.dla.mil.

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 F2091 − 15

Key:
SD1 Diameter of spherical socket SR Retention element distance from SD2
SD2 Retentive or nonretentive entry diameter SH Overall height
SD3 Effective spherical external diameter SΩ Angle from shell face to SC1 center
SC1 Dome cavity diameter (when present) SP1 Fixation element width or diameter
SC2 Apical cavity diameter (when present) SP2 Fixation element height
SW Minimum wall thickness SP3 Distance to fixation element from shell face
SG Surface texture or coating depth

FIG. 1 Shell Cross Section

Key:
BD2 Retentive or nonretentive entry diameter BH1 Distance from bearing element face
BD3 Relief diameter (entry chamfer, if present, to dome
need not extend through the whole BI Inside depth
circumference) BR Retention element depth
BD4 Effective spherical external diameter Bω Angle of chamfer element from BD2
BD5 Outside diameter of the bearing element to BD3
BD6 Flange diameter (when present) BΩ Angle of augmentation of an
BP Depth of BD2 extended lip
BW Minimum wall thickness BL1 Offset of β from center of BD4
BF Flange thickness (when present)

FIG. 2 Bearing Element Cross Section

distinguishing features (for example, augmentation or lack 5. Material

thereof, holes, and so forth) that would exempt any device from
5.1 The choice of materials is understood to be a necessary,
any requirement of this specification.
4.1.1 Type I—Single-piece acetabular prostheses. but not sufficient, assurance of function of the device made
from them. All devices conforming to this specification shall be
NOTE 2—Specifications to both bearing elements and shell may apply. fabricated from materials with adequate mechanical strength
4.1.2 Type II—Multipiece, modular structure prostheses. and durability, corrosion resistance, and biocompatibility.

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 F2091 − 15

Key:
BD2 Retentive or nonretentive entry diameter Bd4 Minor effective spherical
BD3 Relief diameter (entry chamfer, if present, external diameter
need not extend through the whole Bd5 Minor external diameter
circumference) Bd6 Minor flange diameter (when
BD4 Effective spherical external diameter present)
BD5 Major external diameter BE Eccentricity
BD6 Major flange diameter (when present)

FIG. 3 Plan View of Oval/Eccentric Configuration of Bearing Element and Shell

5.1.1 Mechanical Strength—Various components of ac- by spalling, cracking, detrimental material loss, or detrimental
etabular prostheses have been successfully fabricated from the degradation. The following test methods shall be used (if
following materials: See Specifications F67, F75, F90, F136, applicable): Test Methods F1044, F1147, F1160, and F1978.
F138, F562, F603, F648, F799, F1108, F1185, F1377, F1472,
NOTE 3—In situations in which these tests may not be considered
F1537, F1580; and ISO 5832-1, -3, -4, -9, -12, -12/Cor:1, -14, appropriate, other test methods may be considered.
ISO 5834-1, -2, -3, -4, -5 and ISO 6474-1, -2. However, not all
of these materials may possess sufficient mechanical strength 6.3 There are relevant failure modes listed below which, at
for critical highly stressed components nor for articulating a minimum, shall be considered in the evaluation of the safety
surfaces. Associated standards include Practices F601 and and efficacy of an acetabular prosthesis. The failure modes may
F629 and Guide F2565. be addressed through relevant physical testing, or analytical
5.1.2 Corrosion Resistance—Materials with limited or no analysis (for example, internal stress analysis as a result of
history of successful use for orthopaedic implant application loading).
shall be determined to exhibit corrosion resistance equal to or NOTE 4—There is no current ASTM standard for analytical analysis, but
better than one of the materials listed in 5.1.1 when tested in this is an important consideration. Testing may encompass some combi-
accordance to Test Method F746. nation of static and dynamic loading environments.
5.1.3 Biocompatibility—Materials with limited or no history 6.3.1 Component Disassociation—Devices made from mul-
of successful use for orthopaedic implant application shall be tiple layers or components have disassociated under clinical
determined to exhibit acceptable biological response equal to use (for example, articulating surface from the shell). See Test
or better than one of the materials listed in 5.1.1 when tested in Method F1820.
accordance to Practices F748 and F981 for a given application. 6.3.2 Fixation Failure—Devices have loosened at the inter-
face with the bone or bone cement. Fixation elements have
6. Performance Requirements
failed.
6.1 Structural Requirements—Acetabular prostheses con- 6.3.3 Device Fracture—Partial or complete fracture of ei-
forming to this specification shall be capable of withstanding ther the bearing element or the shell.
normal static and dynamic loading in the physiological range. 6.3.4 Articular Surface Wear—Acetabular prostheses have
It shall also demonstrate wear rates substantially equivalent to failed because of excessive wear through the bearing element
or less than sterile ultra-high-molecular-weight polyethylene resulting in particle debris (see Guide F1714).
(Specification F648) with a cobalt chromium couple. See Test 6.3.4.1 Wear Test Methods—Functional (simulated) wear
Method F1820 and Guides F1714 and F2565. tests of the device may be performed to evaluate the wear of
6.2 Metal and Ceramic Coating or Surface Texture the acetabular bearing surface, according to ISO 14242–1 or
Integrity—The coating shall be free of detrimental blisters, ISO 14242–3. Since it is unlikely that one set of test conditions
delaminations, contamination, or poorly defined coating can simulate all aspects of hip function, it is recommended that
boundaries when viewed with no magnification. It shall not fail various test conditions be considered. Consideration may be

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 F2091 − 15
given to effects such as third-body abrasive interaction, high 8. Finish and Appearance
cup angle, micro-separation, stop-dwell-start (stiction), and 8.1 Bearing Element Finish—Acetabular prostheses con-
higher loading conditions. forming to this specification shall be finished in accordance
6.3.4.2 Evaluation of Wear may be performed using gravi- with Specification F2033.
metric techniques and changes in dimensional form (the latter
being applicable to hard-on-hard articulating surfaces only) in 8.2 In accordance with Practices F86 and F983, items
accordance with ISO 14242–2. Consideration may also be conforming to this specification shall be marked as follows in
given to other evaluation methods such as semiquantitative order of priority where space permits: manufacturer, material,
measures of damage assessment and measurement of friction lot number, catalog number, and size. Additional information
factors. may include a designation for alignment.
9. Supplementary Requirements
7. Dimensions
9.1 Sterilization:
7.1 Acetabular prostheses conforming to this specification 9.1.1 The component shall receive a dosage/exposure suffi-
should be fabricated in accordance with the general configu- cient to assure sterility. The dose/exposure shall be applied so
ration illustrated in Figs. 1-3. as to maintain the functional geometry of the component.
7.2 If one of the components is not radiopaque, it may be 9.1.2 The packaging materials of all components that are to
appropriately marked for radiographic evaluation. Radio- be resterilized shall be discarded and the component repack-
graphic markers have been used in the past and are considered aged before sterilization.
noncritical and may not be necessary. If a radiographic marker
is used, it should be placed in a noncritical area to avoid 10. Keywords
degrading the structural and functional properties of the device. 10.1 acetabulum; arthroplasty; prosthesis

APPENDIX

(Nonmandatory Information)

X1. RATIONALE STATEMENT

X1.1 The objectives of this specification are to establish dure may occur solely as a result of host factors not at all
common terminology, define currently acceptable materials, set influenced by properties of the device components.
forth dimensional requirements, and provide guidelines for
mechanical performance for acetabular components used for X1.5 Range of Motion—In addition, failures as a result of
total hip replacement. The devices are intended for use in limited range of motion may be caused by inappropriate sizing
patients who are skeletally mature, under conditions of im- of implants, malpositioning of implants, and the influence of
posed dynamic loads, in a corrosive environment, with virtu- soft tissue. It is strongly recommended that a range of motion
ally continuous motion at the bearing surfaces. analysis be conducted on the “worst-case” acetabular
component, femoral head, and stem combinations. See Test
X1.2 Total hip replacement parts are intended for use in Method F2582 and ISO 21535.
patients who are skeletally mature and have degeneration of
both the femoral head and the acetabulum. The requirements of X1.6 Performance Requirements—Laboratory testing, even
this specification are based upon more than 40 years of with accurately simulated imposed loading, a corrosive envi-
successful clinical experience with this type of implant. They ronment of electrolytes, and complex constituents of body
identify those factors recognized to affect prosthesis perfor- fluids, cannot accurately predict performance over many de-
mance and longevity. It is recognized, however, that failure of cades of use in vivo. In vivo performance is influenced by many
an arthroplasty can occur as a result of factors completely factors including patient weight, activity, and so forth.
unrelated to the characteristics of the prosthesis.
X1.7 Materials—The materials listed in 5.1 document the
X1.3 This specification identifies those factors felt by the state of the art of those clinical uses for this application as of
committee to be important to provide useful, safe prosthesis the time of initial approval of this specification. Use of these
life. Specific performance limits are drawn from in vitro data materials does not, in and of itself, guarantee a successful
on devices and materials that have shown acceptable clinical design, and use of other materials may be equally successful.
experience. The necessary corrosion resistance and biocompatibility re-
quirements provide baseline assurance for the acceptance of
X1.4 It is recognized that failures of an arthroplasty can new materials by the body.
occur even though the components are intact. This is true
owing to the composite which is the goal of the surgical X1.8 Dimensions and Tolerances—Dimensions and toler-
procedure, consisting of the implant components, host bone, ances are described by standard ANSI documents for engineer-
and surrounding tissue and body fluids. Failure of the proce- ing design for sphericity, concentricity, and surface finish.

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 F2091 − 15
Because of the modularity of designs, standard nomenclature X1.9 Finishing and Appearance—The information listed in
and dimensioning of parts should be assured to assist the 8.2 was felt by the committee to be necessary to assist the
surgeon in selecting appropriate matching components. surgeon in assuring the implantation of the proper device and
in assisting in the proper analysis of explanted devices.

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