ASTM F2887-12

Standard Specification for Total Elbow Prostheses

SCOPE
1.1 This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement (“hemi”) prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex.  
1.2 Included within the scope of this specification are elbow prosthesis components for primary and revision surgery with linked and non-linked designs and components implanted with or without use of bone cement.  
1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. In addition, those characteristics determined to be important to the in vivo performance of the prosthesis are defined. However, compliance with this specification does not itself mean that a device that will provide satisfactory clinical performance.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

General Information

• Status: Historical
• Publication Date: 14-Dec-2012
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2887 −12
Standard Specification for
Total Elbow Prostheses
This standard is issued under the fixed designation F2887; 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 F565 PracticeforCareandHandlingofOrthopedicImplants
and Instruments
1.1 Thisspecificationcoverstotalelbowreplacement(TER)
F648 Specification for Ultra-High-Molecular-Weight Poly-
prostheses and hemi-elbow replacement (“hemi”) prostheses
ethylene Powder and Fabricated Form for Surgical Im-
usedtoprovidefunctioningarticulationbyemployinghumeral,
plants
ulnar,and/orradialcomponentsthatallowfortherestorationof
F732 Test Method for Wear Testing of Polymeric Materials
motion of the human elbow joint complex.
Used in Total Joint Prostheses
1.2 Included within the scope of this specification are elbow
F746 Test Method for Pitting or Crevice Corrosion of
prosthesis components for primary and revision surgery with
Metallic Surgical Implant Materials
linked and non-linked designs and components implanted with
F748 PracticeforSelectingGenericBiologicalTestMethods
or without use of bone cement.
for Materials and Devices
1.3 This specification is intended to provide basic descrip- F799 Specification for Cobalt-28Chromium-6Molybdenum
tions of material and prosthesis geometry. In addition, those
Alloy Forgings for Surgical Implants (UNS R31537,
characteristics determined to be important to the in vivo
R31538, R31539)
performance of the prosthesis are defined. However, compli-
F983 Practice for Permanent Marking of Orthopaedic Im-
ance with this specification does not itself mean that a device
plant Components
that will provide satisfactory clinical performance.
F1044 Test Method for Shear Testing of Calcium Phosphate
Coatings and Metallic Coatings
1.4 The values stated in SI units are to be regarded as
F1108 Specification for Titanium-6Aluminum-4Vanadium
standard. No other units of measurement are included in this
Alloy Castings for Surgical Implants (UNS R56406)
standard.
F1147 Test Method for Tension Testing of Calcium Phos-
2. Referenced Documents phate and Metallic Coatings
F1160 Test Method for Shear and Bending Fatigue Testing
2.1 ASTM Standards:
of Calcium Phosphate and Metallic Medical and Compos-
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
ite Calcium Phosphate/Metallic Coatings
Alloy Castings and Casting Alloy for Surgical Implants
F1223 Test Method for Determination of Total Knee Re-
(UNS R30075)
placement Constraint
F86 Practice for Surface Preparation and Marking of Metal-
F1377 Specification for Cobalt-28Chromium-6Molybdenum
lic Surgical Implants
Powder for Coating of Orthopedic Implants (UNS
F90 Specification for Wrought Cobalt-20Chromium-
R30075)
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
F1472 Specification for Wrought Titanium-6Aluminum-
tions (UNS R30605)
4VanadiumAlloy for Surgical ImplantApplications (UNS
F136 Specification for Wrought Titanium-6Aluminum-
R56400)
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
F1537 Specification for Wrought Cobalt-28Chromium-
Implant Applications (UNS R56401)
6Molybdenum Alloys for Surgical Implants (UNS
F451 Specification for Acrylic Bone Cement
R31537, UNS R31538, and UNS R31539)
F1580 Specification for Titanium and Titanium-6
This test method is under the jurisdiction ofASTM Committee F04 on Medical
Aluminum-4 Vanadium Alloy Powders for Coatings of
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
Surgical Implants
F04.22 on Arthroplasty.
F1814 Guide for Evaluating Modular Hip and Knee Joint
Current edition approved Dec. 15, 2012. Published March 2013. DOI: 10.1520/
F2887–12.
Components
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F2759 Guide for Assessment of the Ultra High Molecular
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
WeightPolyethylene(UHMWPE)UsedinOrthopedicand
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Spinal Devices
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2887−12
2.2 ISO Standards: 3.1.1 bearing surface, n—part of the prosthetic component
ISO 5832–3 Implants for Surgery—Metallic Materials— that articulates against the counter surface of the natural or
Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy prosthetic elbow joint.
ISO 5832–4 Implants for Surgery—Metallic Materials—
3.1.2 extension, n—rotation of the ulna and radius away
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
from the humerus around the elbow joint axis in the sagittal
ISO 5832–12 Implants for Surgery—Metallic Materials—
plane.
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
3.1.3 flexion, n—rotation of the ulna and radius towards the
ISO 5834–2 Implants for Surgery—Ultra High Molecular
humerus around the elbow joint axis in the sagittal plane.
Weight Polyethylene—Part 2: Moulded Forms
ISO 6018 Orthopaedic Implants—General Requirements for
3.1.4 hemi-elbow replacement (hemi), n—prosthetic part
Marking, Packaging, and Labeling
thatsubstitutesforthenaturalhumero-ulnar,radio-ulnarand/or
ISO 10993 Biological Evaluation of Medical Devices—Part
humero-radial articulating surfaces in the human elbow in
I: Evaluation and Testing Within a Risk Management
whichonlyonehalfofthearticulatingsurfacesisreplaced.The
Process
prosthesis is expected to articulate with the remaining natural
ISO 14243–1 Implants for Surgery—Wear of Total Knee-
biological surface(s).
Joint Prostheses—Part 1: Loading and Displacement Pa-
3.1.5 humeral component, n—component fixed to the hu-
rameters for Wear-testing Machines with Load Control
merus for articulation with the natural or prosthetic ulnar
and Corresponding Environmental Conditions for Test
and/or radial component(s), typically consisting of two major
ISO 14243–2 Implants for Surgery—Wear of Total Knee-
components: a fixation stem, and a bearing surface.
joint Prostheses—Part 2: Methods of Measurement
3.1.6 interlock, n—mechanical design feature used to in-
ISO 14243–3 Implants for Surgery—Wear of Total Knee-
crease the capture of one component within another to restrict
joint Prostheses—Part 3: Loading and Displacement Pa-
unwanted displacement between components (that is, locking
rameters for Wear-testing Machines with Displacement
mechanism for modular components such as a bearing surface
Control and Corresponding Environmental Conditions for
to a metallic stem component).
Test
2.3 FDA Documents:
3.1.7 laxity, n—intentional looseness in the fit between
21 CFR 888.3150 Elbow Joint Metal/Polymer Constrained linked style elbow prosthetic components (typically the
Cemented Prosthesis
humero-ulnar components) that allows small, secondary out-
21 CFR 888.3160 Elbow Joint Metal/Polymer Semi- of-plane motions during primary motion to avoid a “fully
constrained Cemented Prosthesis
constrained” or “rigid” connection.
21 CFR 888.3170 Elbow Joint Radial (Hemi-elbow) Poly-
3.1.8 linked, n—a style of total elbow prosthesis in which
mer Prosthesis
the humeral and ulnar components are physically connected by
21 CFR 888.3180 Elbow Joint Humeral (Hemi-elbow) Me-
a linking mechanism to prevent disassociation (dislocation)
tallic Uncemented Prosthesis
while allowing motion in selected directions.
21 CFR 888.6 Degree of Constraint
3.1.9 non-linked, n—a style of total elbow prosthesis in
Guidance Document for Testing Orthopedic Implants with
which the humeral and ulnar components are not physically
Modified Metallic Surfaces Apposing Bone or Bone
connected by a linking mechanism. These components rely on
Cement
soft tissue or another mechanism to minimize the potential for
Guidance for Industry on the Testing of Metallic Plasma
disassociation (dislocation) of the two components.
Sprayed Coatings on Orthopedic Implants to Support
ReconsiderationofPostmarketSurveillanceRequirements
3.1.10 pronation, n—rotation of the radius medially about
Guidance Document for Testing Non-articulating, Mechani-
the ulna around a superior-inferior axis.
cally Locked Modular Implant Components
3.1.11 radial component, n—component fixed to the radius
Class II Special Controls Guidance Document: Knee Joint
for articulation with the natural or prosthetic humeral and/or
Patellofemorotibial and Femorotibial Metal/Polymer
ulnar component(s), typically consisting of two major compo-
Porous-Coated Uncemented Prostheses; Guidance for In-
nents: a fixation stem and a bearing surface.
dustry and FDA
3.1.12 subluxation, n—instability or partial dislocation
2.4 ANSI/ASME Standard:
which occur when the relative translational or rotational
ANSI/ASME B46.1–1995 Surface Texture (Surface
motion between the humeral and ulnar components reaches an
Roughness, Waviness, and Lay)
extreme where the two components would cease to articulate
over the designated low-friction bearing surfaces.
3. Terminology
3.1.13 supination, n—rotation of the radius laterally about
3.1 Definitions of Terms Specific to This Standard:
the ulna around a superior-inferior axis.
3.1.14 total elbow replacement (TER), n—prosthetic parts
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
that substitute for, at a minimum, the natural opposing humeral
4th Floor, New York, NY 10036, http://www.ansi.org.
and ulnar articulating surfaces in the human elbow. This
Available from Food and Drug Administration (FDA), 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002, http://www.fda.gov. includes both humero-ulnar type devices that are intended to
F2887−12
function with or without the natural radial head and humero- F75, F136, F1377, and F1580. Not all of these materials may
ulnar with humero-radial option type devices that are intended possess sufficient mechanical strength for critical, highly
to replace all three natural articular surfaces of the elbow. stressed components or for articulating surfaces. Confor-
mances of a selected material to its standard and successful
3.1.15 ulnar component, n—component fixed to the ulna for
clinical usage of the material in a previous implant design are
articulation with the natural or prosthetic humeral and/or radial
not sufficient to ensure the strength of an implant. Manufac-
component(s),typicallyconsistingoftwomajorcomponents:a
turing processes and implant design can strongly influence
fixation stem and a bearing surface.
material properties and performance. Therefore, regardless of
3.1.16 valgus, n—deviation of the ulna away from the
the material selected, the elbow prosthesis shall meet the
midline of the body in the frontal plane.
performance requirements of Section 6 of this specification.
3.1.17 varus, n—deviation of the ulna towards the midline
5.1.2 Corrosion Resistance—Materials with limited or no
of the body in the frontal plane.
history of successful use for orthopaedic implant application
shall be determined to exhibit corrosion resistance equal to or
4. Classification
better than one of the materials listed in 5.1.1 when tested in
4.1 The following classification by degree of constraint is
accordance with Test Method F746. If the corrosion resistance
suggested for all total joint prostheses including total elbow
of a material is less than one of the materials listed in 5.1.1
replacementsystemsbasedontheconceptsadoptedbytheU.S.
whentestedinaccordancetoTestMethodF746,itsuseshallbe
Food and Drug Administration (see 2.3).
justified.
4.1.1 Constrained—A“constrained” joint prosthesis is used
5.1.3 Biocompatibility—The biocompatibility of materials
for joint replacement and prevents dislocation of the prosthesis
usedshallbeevaluatedusingariskbasedapproachsuchasthat
inmorethanoneanatomicplaneandconsistsofeitherasingle,
outlined in ISO 10993–1. Practice F748 or ISO 10993 provide
flexible, across-the-joint component or more than one compo-
guidance on types of biologic tests to perform on materials.
nent linked together or affined.
5.1.4 Friction Characteristics—Bearing surface material
4.1.2 Semi-constrained—A “semi-constrained” joint pros-
couples with limited or no history of successful use for
thesis is used for joint replacement and limits translation and
orthopaedic implant application shall be determined to exhibit
rotation of the prosthesis in one or more planes via the
equal or better performance than one of the material couples
geometry of its articulating surfaces. It has no across-the-joint
listed in 5.1.1 when tested in a pin-on-flat or pin-on-disk test
linkage.
apparatus such as described in Test Method F732 with ad-
4.1.3 Currently, most TERs are considered either semi-
equate controls for comparison. A number of different load
constrained or constrained. However, devices within a particu-
levels may be used to cover the range of anticipated stresses
lar classification may allow varying degrees of freedom (that is
between articulating components.
translation, rotation, and so forth). Currently, TERs which
NOTE 1—Clinically successful elbow prostheses have utilized either
containalinkagemechanismareclassifiedas“constrained”per
CoCrMo alloy or Ti alloy articulating against UHMWPE. The wear
4.1.1 yet these devices are often referred to as “sloppy hinge”
behavior of Ti alloy articulating against UHMWPE in the presence of a
or “linked, semi-constrained” in the peer-reviewed literature in
third body (for example, bone or bone cement particles) has been
demonstrated to be less than that of CoCrMo alloy articulating against
reference to the laxity built into the linkage mechanism to
UHMWPE under similar conditions. Therefore, appropriate surface treat-
prevent a completely constrained (rigid) connection. These
ments of the Ti alloy surface should be considered to improve wear
types of devices allow some amount of varus/valgus and rotary
performance of a Ti alloy/UHMWPE bearing couple in the presence of a
motion between the humeral and ulnar components in addition
third body as described in Section 7-J of Class II Special Controls
to the primary flexion/extension motion. Devices without this Guidance Document: Knee Joint Patellofemorotibial and Femorotibial
Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for
additional laxity are often referred to as “fully constrained” in
Industry and FDA.
the literature. See X2.4 for additional discussion.
6. Performance Requirements
5. Material
6.1 Component Function—Each component for total or
5.1 The choice of materials is understood to be a necessary
hemi elbow replacement is expected to f
...