ASTM F2887-23

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 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.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 28-Feb-2023
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Refers: ASTM F1223-20 - Standard Test Method for Determination of Total Knee Replacement Constraint
• Effective Date: 15-Jun-2020
• Refers: ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• Effective Date: 01-Mar-2020
• Refers: ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• Effective Date: 01-Dec-2019
• Refers: ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• Effective Date: 15-May-2019
• Refers: ASTM F1580-18 - Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
• Effective Date: 15-Nov-2018
• Refers: ASTM F983-86(2018) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
• Effective Date: 01-Feb-2018
• Refers: ASTM F1044-05(2017)e1 - Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
• Effective Date: 01-Dec-2017
• Refers: ASTM F1160-14(2017)e1 - Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• Effective Date: 01-Dec-2017
• Refers: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 01-Sep-2017
• Refers: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Apr-2016
• Refers: ASTM F1160-14 - Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
• Effective Date: 01-Jun-2014
• Refers: ASTM F1223-14 - Standard Test Method for Determination of Total Knee Replacement Constraint
• Effective Date: 15-May-2014
• Refers: ASTM F983-86(2013) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
• Effective Date: 01-Oct-2013
• Refers: ASTM F565-04(2013) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Oct-2013
• Refers: ASTM F648-13 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 01-Jul-2013

Overview

ASTM F2887-23: Standard Specification for Total Elbow Prostheses provides a comprehensive specification for total elbow replacement (TER) and hemi-elbow replacement prostheses. This standard was developed by ASTM International to harmonize requirements for prosthetic elbow devices, including linked and non-linked designs, for both primary and revision surgeries. The specification addresses critical features such as material requirements, prosthesis geometry, functional characteristics, dimensions, surface finish, marking, and packaging for devices intended to restore the motion and function of the human elbow joint complex. It is a vital resource for manufacturers, clinicians, and regulatory bodies aiming for consistency and reliability in elbow arthroplasty products.

Key Topics

• Scope of Application: Covers both total and hemi-elbow prostheses, including components with or without bone cement, and for various surgical contexts including primary and revision surgeries.
• Material Requirements: Specifies acceptable materials, including various titanium and cobalt-chromium alloys, and ultra-high-molecular-weight polyethylene (UHMWPE), ensuring mechanical strength, durability, corrosion resistance, and biocompatibility.
• Design Classification: Classifies joint prostheses as constrained or semi-constrained, aligning with FDA guidelines for device evaluation.
• Dimensions and Tolerances: Defines key component measurements (such as stem length, bearing thickness) and references industry practices for dimensional accuracy.
• Performance Criteria: Outlines expectations for component function, fatigue resistance, range of motion, subluxation resistance, modular connection integrity, and wear.
• Surface Finish and Marking: Establishes surface roughness parameters and requirements for permanent, clear device marking for traceability.

Applications

The ASTM F2887-23 standard is relevant for a variety of practical applications, including:

• Device Manufacturing: Provides manufacturers with minimum requirements for the selection of materials, production methods, and quality control processes for elbow prostheses.
• Product Development: Supports the safe design of new prosthetic elbow devices through clear performance, durability, and biomechanical guidelines.
• Testing and Validation: Guides the physical testing of prosthetic components for wear, fatigue, and in vivo load resistance, referencing procedures recognized by regulatory agencies and industry practices.
• Clinical Use: Assists surgeons and clinical teams in selecting prostheses with validated safety, performance, and longevity, and in understanding device labeling and packaging.
• Regulatory Compliance: Facilitates device submissions and approvals with FDA, ISO, and other regulatory bodies by aligning with international principles and referenced standards.

Related Standards

ASTM F2887-23 references a broad range of related materials, test methods, and regulatory guidelines to ensure safety and efficacy of total elbow prostheses:

• ASTM F75, F136, F648, F732: Material and wear test methods for orthopaedic implants.
• ASTM F983, F1044, F1108, F1147, F1160, F1814: Standards for marking, mechanical testing, and evaluation of implant design and performance.
• ISO 5832-3, ISO 5832-4, ISO 10993-1: International standards for metallic implant materials and biological evaluation.
• FDA 21 CFR 888.3150, 888.3160, 888.3170, 888.3180: US regulations for various types of elbow joint prostheses.
• ANSI/ASME B46.1-1995: Surface texture and finishing requirements for metallic and polymeric implant surfaces.

By integrating these referenced standards, ASTM F2887-23 supports harmonized quality, safety, and testing protocols across the global orthopaedic device industry, making it a cornerstone document for successful total elbow replacement outcomes.

Keywords: ASTM F2887-23, total elbow prosthesis, TER, hemi-elbow replacement, elbow joint prosthesis, arthroplasty, orthopaedic implant standards, elbow replacement material, prosthesis design, regulatory compliance, elbow implant testing, surface roughness, device marking.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2887 − 23
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 F90 Specification for Wrought Cobalt-20Chromium-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
1.1 This specification covers total elbow replacement (TER)
tions (UNS R30605)
prostheses and hemi-elbow replacement (“hemi”) prostheses
F136 Specification for Wrought Titanium-6Aluminum-
used to provide functioning articulation by employing humeral,
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
ulnar, and/or radial components that allow for the restoration of
Implant Applications (UNS R56401)
motion of the human elbow joint complex.
F451 Specification for Acrylic Bone Cement
1.2 Included within the scope of this specification are elbow
F565 Practice for Care and Handling of Orthopedic Implants
prosthesis components for primary and revision surgery with
and Instruments
linked and non-linked designs and components implanted with
F648 Specification for Ultra-High-Molecular-Weight Poly-
or without use of bone cement.
ethylene Powder and Fabricated Form for Surgical Im-
1.3 This specification is intended to provide basic descrip-
plants
tions of material and prosthesis geometry. In addition, those
F732 Test Method for Wear Testing of Polymeric Materials
characteristics determined to be important to the in vivo
Used in Total Joint Prostheses
performance of the prosthesis are defined. However, compli-
F746 Test Method for Pitting or Crevice Corrosion of
ance with this specification does not itself mean that a device
Metallic Surgical Implant Materials
will provide satisfactory clinical performance.
F748 Practice for Selecting Generic Biological Test Methods
1.4 The values stated in SI units are to be regarded as
for Materials and Devices
standard. No other units of measurement are included in this
F799 Specification for Cobalt-28 Chromium-6 Molybdenum
standard.
Alloy Forgings for Surgical Implants (UNS R31537,
1.5 This international standard was developed in accor- R31538, R31539)
dance with internationally recognized principles on standard- F983 Practice for Permanent Marking of Orthopaedic Im-
ization established in the Decision on Principles for the
plant Components
Development of International Standards, Guides and Recom-
F1044 Test Method for Shear Testing of Calcium Phosphate
mendations issued by the World Trade Organization Technical
Coatings and Metallic Coatings
Barriers to Trade (TBT) Committee.
F1108 Specification for Titanium-6Aluminum-4Vanadium
Alloy Castings for Surgical Implants (UNS R56406)
2. Referenced Documents
F1147 Test Method for Tension Testing of Calcium Phos-
2.1 ASTM Standards:
phate and Metallic Coatings
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F1160 Test Method for Shear and Bending Fatigue Testing
Alloy Castings and Casting Alloy for Surgical Implants
of Calcium Phosphate and Metallic Medical and Compos-
(UNS R30075)
ite Calcium Phosphate/Metallic Coatings
F86 Practice for Surface Preparation and Marking of Metal-
F1223 Test Method for Determination of Total Knee Re-
lic Surgical Implants
placement Constraint
F1377 Specification for Cobalt-28Chromium-6Molybdenum
Powder for Medical Devices (UNS R30075, UNS
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
R31537, and UNS R31538)
Subcommittee F04.22 on Arthroplasty.
F1472 Specification for Wrought Titanium-6Aluminum-
Current edition approved March 1, 2023. Published March 2023. Originally
4Vanadium Alloy for Surgical Implant Applications (UNS
approved in 2012. Last previous edition approved in 2017 as F2887 – 17. DOI:
10.1520/F2887-23.
R56400)
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F1537 Specification for Wrought Cobalt-28Chromium-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
6Molybdenum Alloys for Surgical Implants (UNS
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. R31537, UNS R31538, and UNS R31539)
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2887 − 23
F1580 Specification for Titanium and Titanium-6 Porous-Coated Uncemented Prostheses; Guidance for In-
Aluminum-4 Vanadium Alloy Powders for Coatings of dustry and FDA
Surgical Implants 2.4 ANSI/ASME Standard:
F1814 Guide for Evaluating Modular Hip and Knee Joint ANSI/ASME B46.1-1995 Surface Texture (Surface
Components Roughness, Waviness, and Lay)
F2759 Guide for Assessment of the Ultra-High Molecular
3. Terminology
Weight Polyethylene (UHMWPE) Used in Orthopedic and
3.1 Definitions of Terms Specific to This Standard:
Spinal Devices
3.1.1 bearing surface, n—part of the prosthetic component
2.2 ISO Standards:
that articulates against the counter surface of the natural or
ISO 5832-3 Implants for Surgery—Metallic Materials—Part
prosthetic elbow joint.
3: Wrought Titanium 6-Aluminum 4-Vandium Alloy
ISO 5832-4 Implants for Surgery—Metallic Materials—Part 3.1.2 extension, n—rotation of the ulna and radius away
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
3.1.4 hemi-elbow replacement (hemi), n—prosthetic part
ISO 6018 Orthopaedic Implants—General Requirements for
that substitutes for the natural humero-ulnar, radio-ulnar,
Marking, Packaging, and Labeling
and/or humero-radial articulating surfaces in the human elbow
ISO 10993-1 Biological Evaluation of Medical Devices—
in which only one half of the articulating surfaces is replaced.
Part 1: Evaluation and Testing Within a Risk Management
The prosthesis is expected to articulate with the remaining
Process
natural biological surface(s).
ISO 14243-1 Implants for Surgery—Wear of Total Knee-
3.1.5 humeral component, n—component fixed to the hu-
Joint Prostheses—Part 1: Loading and Displacement Pa-
merus for articulation with the natural or prosthetic ulnar
rameters for Wear-testing Machines with Load Control
and/or radial component(s), typically consisting of two major
and Corresponding Environmental Conditions for Test
components: a fixation stem, and a bearing surface.
ISO 14243-2 Implants for Surgery—Wear of Total Knee-
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
3.1.7 laxity, n—intentional looseness in the fit between
2.3 FDA Documents:
linked style elbow prosthetic components (typically the
21 CFR 888.3150 Elbow Joint Metal/Polymer Constrained
humero-ulnar components) that allows small, secondary out-
Cemented Prosthesis
of-plane motions during primary motion to avoid a “fully
21 CFR 888.3160 Elbow Joint Metal/Polymer Semi-
constrained” or “rigid” connection.
constrained Cemented Prosthesis
3.1.8 linked, n—a style of total elbow prosthesis in which
21 CFR 888.3170 Elbow Joint Radial (Hemi-elbow) Poly-
the humeral and ulnar components are physically connected by
mer Prosthesis
a linking mechanism to prevent disassociation (dislocation)
21 CFR 888.3180 Elbow Joint Humeral (Hemi-elbow) Me-
while allowing motion in selected directions.
tallic Uncemented Prosthesis
3.1.9 non-linked, n—a style of total elbow prosthesis in
21 CFR 888.6 Degree of Constraint
which the humeral and ulnar components are not physically
Guidance Document for Testing Orthopedic Implants with
connected by a linking mechanism. These components rely on
Modified Metallic Surfaces Apposing Bone or Bone
soft tissue or another mechanism to minimize the potential for
Cement
disassociation (dislocation) of the two components.
Guidance for Industry on the Testing of Metallic Plasma
3.1.10 pronation, n—rotation of the radius medially about
Sprayed Coatings on Orthopedic Implants to Support
the ulna around a superior-inferior axis.
Reconsideration of Postmarket Surveillance Requirements
Guidance Document for Testing Non-articulating, Mechani-
3.1.11 radial component, n—component fixed to the radius
cally Locked Modular Implant Components
for articulation with the natural or prosthetic humeral and/or
Class II Special Controls Guidance Document Knee Joint
ulnar component(s), typically consisting of two major compo-
Patellofemorotibial and Femorotibial Metal/Polymer
nents: a fixation stem and a bearing surface.
3.1.12 subluxation, n—instability or partial dislocation
which occurs when the relative translational or rotational
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
motion between the humeral and ulnar components reaches an
4th Floor, New York, NY 10036, http://www.ansi.org.
extreme where the two components would cease to articulate
Available from Food and Drug Administration (FDA), 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002, http://www.fda.gov. over the designated low-friction bearing surfaces.
F2887 − 23
3.1.13 supination, n—rotation of the radius laterally about 5.1.1 Mechanical Strength—Various metallic components
the ulna around a superior-inferior axis. of elbow replacement devices have been successfully fabri-
cated from materials, as examples, found in ASTM Specifica-
3.1.14 total elbow replacement (TER), n—prosthetic parts
tions F75, F90, F136, F799, F1108, F1377, F1472, and F1537
that substitute for, at a minimum, the natural opposing humeral
and ISO 5832-3. Polymeric bearing components have been
and ulnar articulating surfaces in the human elbow. This
fabricated from ultra-high-molecular-weight polyethylene
includes both humero-ulnar type devices that are intended to
(UHMWPE) as an example, as specified in Specification F648,
function with or without the natural radial head and humero-
Guide F2759, or ISO 5834-2. Porous coatings have been
ulnar with humero-radial option type devices that are intended
fabricated from example materials specified in Specifications
to replace all three natural articular surfaces of the elbow.
F75, F136, F1377, and F1580. Not all of these materials may
3.1.15 ulnar component, n—component fixed to the ulna for
possess sufficient mechanical strength for critical, highly
articulation with the natural or prosthetic humeral and/or radial
stressed components or for articulating surfaces. Confor-
component(s), typically consisting of two major components: a
mances of a selected material to its standard and successful
fixation stem and a bearing surface.
clinical usage of the material in a previous implant design are
3.1.16 valgus, n—deviation of the ulna away from the
not sufficient to ensure the strength of an implant. Manufac-
midline of the body in the frontal plane.
turing processes and implant design can strongly influence
3.1.17 varus, n—deviation of the ulna towards the midline material properties and performance. Therefore, regardless of
the material selected, the elbow prosthesis shall meet the
of the body in the frontal plane.
performance requirements of Section 6 of this specification.
5.1.2 Corrosion Resistance—Materials with limited or no
4. Classification
history of successful use for orthopaedic implant application
4.1 The following classification by degree of constraint is
shall be determined to exhibit corrosion resistance equal to or
suggested for all total joint prostheses including total elbow
better than one of the materials listed in 5.1.1 when tested in
replacement systems based on the concepts adopted by the U.S.
accordance with Test Method F746. If the corrosion resistance
Food and Drug Administration (21 CFR 888.6, 21 CFR
of a material is less than one of the materials listed in 5.1.1
888.3150, 21 CFR 888.3160, 21 CFR 888.3170, 21 CFR
when tested in accordance to Test Method F746, its use shall be
888.3180; 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
used shall be evaluated using a risk-based approach such as
in more than one anatomic plane and consists of either a single,
that outlined in ISO 10993-1. Practice F748 or ISO 10993
flexible, across-the-joint component or more than one compo-
provide guidance on types of biologic tests to perform on
nent linked together or affined.
materials.
4.1.2 Semi-Constrained—A “semi-constrained” joint pros-
5.1.4 Friction Characteristics—Bearing surface material
thesis is used for joint replacement and limits translation and
couples with limited or no history of successful use for
rotation of the prosthesis in one or more planes via the
orthopaedic implant application shall be determined to exhibit
geometry of its articulating surfaces. It has no across-the-joint
equal or better performance than one of the material couples
linkage.
listed in 5.1.1 when tested in a pin-on-flat or pin-on-disk test
4.1.3 Currently, most TERs are considered either semi-
apparatus such as described in Test Method F732 with ad-
constrained or constrained. However, devices within a particu-
equate controls for comparison. A number of different load
lar classification may allow various degrees of freedom (that is,
levels may be used to cover the range of anticipated stresses
translation(s) and rotation(s)). Currently, TERs which contain a
between articulating components.
linkage mechanism are classified as “constrained” per 4.1.1 yet
these devices are often referred to as “sloppy hinge” or “linked, NOTE 1—Clinically successful elbow prostheses have utilized either
CoCrMo alloy or Ti alloy articulating against UHMWPE. The wear
semi-constrained” in the peer-reviewed literature in reference
behavior of Ti alloy articulating against UHMWPE in the presence of a
to the laxity built into the linkage mechanism to prevent a
third body (for example, bone or bone cement particles) has been
completely constrained (rigid) connection. These types of
demonstrated to be less than that of CoCrMo alloy articulating against
devices allow some amount of varus/valgus and rotary motion
UHMWPE under similar conditions. Therefore, appropriate surface treat-
between the humeral and ulnar components in addition to the ments of the Ti alloy surface should be considered to improve wear
performance of a Ti alloy/UHMWPE bearing couple in the presence of a
primary flexion/extension motion. Devices without this addi-
third body as described in Section 7-J of Class II Special Controls
tional laxity are often referred to as “fully constrained” in the
Guidance Document: Knee Joint Patellofemorotibial and Femorotibial
literature. See X2.4 for additional discussion.
Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for
Industry and FDA.
5. Material
6. Performance Requirements
5.1 The choice of materials is understood to be a necessary
but not sufficient assurance of function of the device made 6.1 Component Function—Each component for total elbow
from them. All devices conforming to this specification shall be replacement or hemi-elbow replacement is expected to func-
fabricated from materials with adequate mechanical strength, tion as intended when manufactured in accordance with good
durability, corrosion resistance, biocompatibility, and wear manufacturing practices and to the requirements of this speci-
resistance. fication. The components shall be capable of withstanding
F2887 − 23
anticipated static and dynamic physiologic loads without into consideration loads, component sizes, thickness of the
compromising their function for the intended use and biologi- polymer bearing component, bony support, locking
cal environment (1-4). All components used for experimental mechanism, edge loading, misalignments, and how these can
measures of performance shall be equivalent to the finished affect the individual design. One such bench testing method-
product in form and material. Components shall be sterilized if
ology is described in Kincaid et al. (18).
it will affect their performance.
NOTE 4—In situations in which the pin-on-flat test may not be
NOTE 2—Computer models may be used to evaluate many of the
considered appropriate, other tests (for example, simulation of elbow
functional characteristics if appropriate material properties and functional prostheses wear performance testing similar to those described in ISO
constraints are included and the computer models have been validated
14243-1, -2, -3 (parts 1 to 3) for knee prostheses) may be considered.
with experimental tests.
6.2 Integrity of Modular Connections—All modular compo-
NOTE 3—No recognized consensus test methodologies for TER yet
exist. Implant testing should reflect current clinical failures and potential nents shall be evaluated for the integrity of their connecting
failure modes particular to the implant. To facilitate such testing, several
mechanisms per the guidance provided in Guidance Document
references on elbow prostheses including bench testing methods reported
for Testing Non-Articulating, Mechanically Locked Modular
in the peer-reviewed literature have been compiled. In the design of elbow
Implant Components. As suggested in Guide F1814, static and
implants, this background information may be helpful in determining
dynamic shear tests, bending tests, and tensile tests or any
worst-case elbow joint forces. However, these joint reaction forces are
based upon limited available data of the forces and moments in the healthy
combination may be necessary to determine the performance
elbow and include assumptions to address gaps in understanding. In order
characteristics. The connecting mechanisms shall show suffi-
to generate pass/fail criteria (that is, forces, angles, and number of cycles)
cient integrity for the range of loads anticipated for the
for a particular elbow prosthesis, one should take into consideration the
application. Alternatively, a “construct fatigue” or “durability”
anticipated patient population, worst-case physiological loads and angles,
an appropriate safety factor, the potential for unsupported surfaces, and test may be performed to demonstrate integrity of a modular
include in the final report all assumptions made in developing the test
system in its entirety. Such a test shall simulate worst-case
methodology.
scenarios to demonstrate that the assembled component(s) are
6.1.1 In-Vivo Loading Profiles—Kincaid and An published a
able to withstand anticipated physiological loading conditions
literature review of humeral-ulnar (HU) biomechanics that
and are not susceptible to the failure modes that have been
includes discussions around basic biomechanics, deriving joint
reported in the literature. The worst-case scenarios should take
reaction forces (JRF), types of activities of daily living (ADL), into consideration patient activity levels, loads, component
and frequency of motions. From these data, they propose
sizes, component misalignment, thickness of bearing inserts,
scalable in-vitro loading profiles for bench testing purposes (4). bony support, locking mechanism, edge loading, contact of
6.1.2 Stem Fracture—Stem fracture has been reported clini-
dissimilar metals with respect to the potential for galvanic
cally (5-9). Individual humeral, ulnar, and radial components corrosion and/or mechanically assisted crevice corrosion
should be fatigue tested using relevant or analogous test
(MACC) and how these fac
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2887 − 17 F2887 − 23
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
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 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.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F451 Specification for Acrylic Bone Cement
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F732 Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
This test method specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
Current edition approved Jan. 1, 2017March 1, 2023. Published March 2017March 2023. Originally approved in 2012. Last previous edition approved in 20122017 as
F2887F2887 – 17.-12. DOI: 10.1520/F2887–17.10.1520/F2887-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1160 Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium
Phosphate/Metallic Coatings
F1223 Test Method for Determination of Total Knee Replacement Constraint
F1377 Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and
UNS R31538)
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F1580 Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
F1814 Guide for Evaluating Modular Hip and Knee Joint Components
F2759 Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal
Devices
2.2 ISO Standards:
ISO 5832–35832-3 Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy
ISO 5832–45832-4 Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
ISO 5832–125832-12 Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
ISO 5834–25834-2 Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms
ISO 6018 Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling
ISO 10993–110993-1 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management
Process
ISO 14243–114243-1 Implants for Surgery—Wear of Total Knee-Joint Prostheses—Part 1: Loading and Displacement
Parameters for Wear-testing Machines with Load Control and Corresponding Environmental Conditions for Test
ISO 14243–214243-2 Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 2: Methods of Measurement
ISO 14243–314243-3 Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement
Parameters for Wear-testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
2.3 FDA Documents:
21 CFR 888.3150 Elbow Joint Metal/Polymer Constrained Cemented Prosthesis
21 CFR 888.3160 Elbow Joint Metal/Polymer Semi-constrained Cemented Prosthesis
21 CFR 888.3170 Elbow Joint Radial (Hemi-elbow) Polymer Prosthesis
21 CFR 888.3180 Elbow Joint Humeral (Hemi-elbow) Metallic Uncemented Prosthesis
21 CFR 888.6 Degree of Constraint
Guidance Document for Testing Orthopedic Implants for Testing Orthopedic Implants with Modified Metallic Surfaces
Apposing Bone or Bone Cement
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration
of Postmarket Surveillance Requirements
Guidance Document for Testing Non-articulating, for Testing Non-articulating, Mechanically Locked Modular Implant
Components
Class II Special Controls Guidance Document:Document Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer
Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA
2.4 ANSI/ASME Standard:
ANSI/ASME B46.1–1995B46.1-1995 Surface Texture (Surface Roughness, Waviness, and Lay)
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bearing surface, n—part of the prosthetic component that articulates against the counter surface of the natural or prosthetic
elbow joint.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from Food and Drug Administration (FDA), 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, http://www.fda.gov.
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3.1.2 extension, n—rotation of the ulna and radius away from the humerus around the elbow joint axis in the sagittal plane.
3.1.3 flexion, n—rotation of the ulna and radius towards the humerus around the elbow joint axis in the sagittal plane.
3.1.4 hemi-elbow replacement (hemi), n—prosthetic part that substitutes for the natural humero-ulnar, radio-ulnarradio-ulnar,
and/or humero-radial articulating surfaces in the human elbow in which only one half of the articulating surfaces is replaced. The
prosthesis is expected to articulate with the remaining natural biological surface(s).
3.1.5 humeral component, n—component fixed to the humerus for articulation with the natural or prosthetic ulnar and/or radial
component(s), typically consisting of two major components: a fixation stem, and a bearing surface.
3.1.6 interlock, n—mechanical design feature used to increase the capture of one component within another to restrict unwanted
displacement between components (that is, locking mechanism for modular components such as a bearing surface to a metallic
stem component).
3.1.7 laxity, n—intentional looseness in the fit between linked style elbow prosthetic components (typically the humero-ulnar
components) that allows small, secondary out-of-plane motions during primary motion to avoid a “fully constrained” or “rigid”
connection.
3.1.8 linked, n—a style of total elbow prosthesis in which the humeral and ulnar components are physically connected by a linking
mechanism to prevent disassociation (dislocation) while allowing motion in selected directions.
3.1.9 non-linked, n—a style of total elbow prosthesis in which the humeral and ulnar components are not physically connected by
a linking mechanism. These components rely on soft tissue or another mechanism to minimize the potential for disassociation
(dislocation) of the two components.
3.1.10 pronation, n—rotation of the radius medially about the ulna around a superior-inferior axis.
3.1.11 radial component, n—component fixed to the radius for articulation with the natural or prosthetic humeral and/or ulnar
component(s), typically consisting of two major components: a fixation stem and a bearing surface.
3.1.12 subluxation, n—instability or partial dislocation which occurs when the relative translational or rotational motion between
the humeral and ulnar components reaches an extreme where the two components would cease to articulate over the designated
low-friction bearing surfaces.
3.1.13 supination, n—rotation of the radius laterally about the ulna around a superior-inferior axis.
3.1.14 total elbow replacement (TER), n—prosthetic parts that substitute for, at a minimum, the natural opposing humeral and
ulnar articulating surfaces in the human elbow. This includes both humero-ulnar type devices that are intended to function with
or without the natural radial head and humero-ulnar with humero-radial option type devices that are intended to replace all three
natural articular surfaces of the elbow.
3.1.15 ulnar component, n—component fixed to the ulna for articulation with the natural or prosthetic humeral and/or radial
component(s), typically consisting of two major components: a fixation stem and a bearing surface.
3.1.16 valgus, n—deviation of the ulna away from the midline of the body in the frontal plane.
3.1.17 varus, n—deviation of the ulna towards the midline of the body in the frontal plane.
4. Classification
4.1 The following classification by degree of constraint is suggested for all total joint prostheses including total elbow replacement
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systems based on the concepts adopted by the U.S. Food and Drug Administration (21 CFR 888.6, 21 CFR 888.3150, 21 CFR
888.3160, 21 CFR 888.3170, 21 CFR 888.3180; see 2.3).
4.1.1 Constrained—A “constrained” joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in
more than one anatomic plane and consists of either a single, flexible, across-the-joint component or more than one component
linked together or affined.
4.1.2 Semi-constrained—Semi-Constrained—A “semi-constrained” joint prosthesis is used for joint replacement and limits
translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no
across-the-joint linkage.
4.1.3 Currently, most TERs are considered either semi-constrained or constrained. However, devices within a particular
classification may allow various degrees of freedom (that is, translation(s) and rotation(s)). Currently, TERs which contain a
linkage mechanism are classified as “constrained” per 4.1.1 yet these devices are often referred to as “sloppy hinge” or “linked,
semi-constrained” in the peer-reviewed literature in reference to the laxity built into the linkage mechanism to prevent a completely
constrained (rigid) connection. These types of devices allow some amount of varus/valgus and rotary motion between the humeral
and ulnar components in addition to the primary flexion/extension motion. Devices without this additional laxity are often referred
to as “fully constrained” in the literature. See X2.4 for additional discussion.
5. Material
5.1 The choice of materials is understood to be a necessary but not sufficient assurance of function of the device made from them.
All devices conforming to this specification shall be fabricated from materials with adequate mechanical strength, durability,
corrosion resistance, biocompatibility, and wear resistance.
5.1.1 Mechanical Strength—Various metallic components of elbow replacement devices have been successfully fabricated from
materials, as examples, found in ASTM Specifications F75, F90, F136, F799, F1108, F1377, F1472, and F1537 and ISO
5832–3.5832-3. Polymeric bearing components have been fabricated from ultra high molecular weight ultra-high-molecular-
weight polyethylene (UHMWPE) as an example, as specified in Specification F648, Guide F2759, or ISO 5834–2.5834-2. Porous
coatings have been fabricated from example materials specified in Specifications F75, F136, F1377, and F1580. Not all of these
materials may possess sufficient mechanical strength for critical, highly stressed components or for articulating surfaces.
Conformances of a selected material to its standard and successful clinical usage of the material in a previous implant design are
not sufficient to ensure the strength of an implant. Manufacturing processes and implant design can strongly influence material
properties and performance. Therefore, regardless of the material selected, the elbow prosthesis shall meet the performance
requirements of Section 6 of this specification.
5.1.2 Corrosion Resistance—Materials with limited or no history of successful use for orthopaedic implant application shall be
determined to exhibit corrosion resistance equal to or better than one of the materials listed in 5.1.1 when tested in accordance with
Test Method F746. If the corrosion resistance of a material is less than one of the materials listed in 5.1.1 when tested in accordance
to Test Method F746, its use shall be justified.
5.1.3 Biocompatibility—The biocompatibility of materials used shall be evaluated using a risk based risk-based approach such as
that outlined in ISO 10993–1.10993-1. Practice F748 or ISO 10993 provide guidance on types of biologic tests to perform on
materials.
5.1.4 Friction Characteristics—Bearing surface material couples with limited or no history of successful use for orthopaedic
implant application shall be determined to exhibit equal or better performance than one of the material couples listed in 5.1.1 when
tested in a pin-on-flat or pin-on-disk test apparatus such as described in Test Method F732 with adequate controls for comparison.
A number of different load levels may be used to cover the range of anticipated stresses between articulating components.
NOTE 1—Clinically successful elbow prostheses have utilized either CoCrMo alloy or Ti alloy articulating against UHMWPE. The wear behavior of Ti
alloy articulating against UHMWPE in the presence of a third body (for example, bone or bone cement particles) has been demonstrated to be less than
that of CoCrMo alloy articulating against UHMWPE under similar conditions. Therefore, appropriate surface treatments of the Ti alloy surface should
be considered to improve wear performance of a Ti alloy/UHMWPE bearing couple in the presence of a third body as described in Section 7-J of Class
II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses;
Guidance for Industry and FDA.
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6. Performance Requirements
6.1 Component Function—Each component for total elbow replacement or hemi-elbow replacement is expected to function as
intended when manufactured in accordance with good manufacturing practices and to the requirements of this specification. The
components shall be capable of withstanding anticipated static and dynamic physiologic loads without compromising their function
for the intended use and biological environment (1-41, 2, 3, 4). All components used for experimental measures of performance
shall be equivalent to the finished product in form and material. Components shall be sterilized if it will affect their performance.
NOTE 2—Computer models may be used to evaluate many of the functional characteristics if appropriate material properties and functional constraints
are included and the computer models have been validated with experimental tests.
NOTE 3—No recognized consensus test methodologies for TER yet exist. Implant testing should reflect current clinical failures and potential failure modes
particular to the implant. To facilitate such testing, several references on elbow prostheses including bench testing methods reported in the peer-reviewed
literature have been compiled. In the design of elbow implants, this background information may be helpful in determining worst-case elbow joint forces.
However, these joint reaction forces are based upon limited available data of the forces and moments in the healthy elbow and include assumptions to
address gaps in understanding. In order to generate pass/fail criteria (that is, forces, angles, and number of cycles) for a particular elbow prosthesis, one
should take into consideration the anticipated patient population, worst-case physiological loads and angles, an appropriate safety factor, the potential for
unsupported surfaces, and include in the final report all assumptions made in developing the test methodology.
6.1.1 In-Vivo Loading Profiles—Kincaid and An published a literature review of humeral-ulnar (HU) biomechanics that includes
discussions around basic biomechanics, deriving Joint Reaction Forcesjoint reaction forces (JRF), types of Activities of Daily
Livingactivities of daily living (ADL), and frequency of motions. From these data, they propose scalable in-vitro loading profiles
for bench testing purposes (4).
6.1.2 Stem Fracture—Stem fracture has been reported clinically (5-9). Individual humeral, ulnar, and radial components should
be fatigue tested using relevant or analogous test methods under appropriate loading conditions (that is, should consider worst-case
scenarios) to address loss of supporting foundation leading to potential deformation and/or component fracture. One such bench
testing methodology is described in Vardarajan et alal. (10).
6.1.3 Link Disassembly—Linked implant disassembly has been reported clinically (8, 9, 1111-14, 12, 13, 14). Assembled (linked)
humeral and ulnar components should be tested using relevant or analogous test methods under appropriate loading conditions (that
is, considering worst-case scenarios) to address loss of constraint leading to component fracture and/or disassembly. One such
bench testing methodology is described in Vardarajan et alal. (14).
6.1.4 Subluxation—Unlinked implant subluxation has been reported clinically (8, 9). Subluxation resistance of assembled
components (that is, dislocation safety factor) should be measured and documented.
6.1.5 Wear—Bearing surface component wear, delamination, and fracture have been reported clinically (6, 8, 9, 12-17). Bearing
components shall be analyzed or tested considering worst-case scenarios to demonstrate that the component can withstand
anticipated physiological loading conditions and is not susceptible to the failure modes that have been reported in the literature.
The worst-case scenarios should take into consideration loads, component sizes, thickness of the polymer bearing component, bony
support, locking mechanism, edge loading, misalignments, and how these can affect the individual design. One such bench testing
methodology is described in Kincaid et alal. (18).
NOTE 4—In situations in which the pin-on-flat test may not be considered appropriate, other tests (for example, simulation of elbow prostheses wear
performance testing similar to those described in ISO 14243–1, –2, –3 (parts 1-3) 14243-1, -2, -3 (parts 1 to 3) for knee prostheses) may be considered.
6.2 Integrity of Modular Connections—All modular components shall be evaluated for the integrity of their connecting
mechanisms per the guidance provided in Guidance Document for Testing Non-articulating,Non-Articulating, Mechanically
Locked Modular Implant Components. As suggested in Guide F1814, static and dynamic shear tests, bending tests, and tensile tests
or any combination may be necessary to determine the performance characteristics. The connecting mechanisms shall show
sufficient integrity for the range of loads anticipated for the application. Alternatively, a “con
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