ASTM F1357-23

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Designation: F1357 − 14 (Reapproved 2019) F1357 − 23
Standard Specification for
Articulating Total Wrist Implants
This standard is issued under the fixed designation F1357; 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 describes total wrist implants, including solid ceramic implants, implants used to provide functioning
articulation by employing radial and carpal components.
1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants
(with or without grommets), and those devices used for custom applications.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
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:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
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)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant
Applications (UNS R30563) (Withdrawn 2005)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
This 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 Nov. 15, 2019Feb. 15, 2023. Published December 2019February 2023. Originally approved in 1991. Last previous edition approved in 20142019
as F1357F1357 – 14 (2019).–14. DOI: 10.1520/F1357-14R19.10.1520/F1357-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
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F1357 − 23
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F629 Practice for Radiography of Cast Metallic Surgical Implants
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1223 Test Method for Determination of Total Knee Replacement Constraint
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)
F2003 Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
F2129 Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Suscepti-
bility of Small Implant Devices
F3306 Test Method for Ion Release Evaluation of Medical Implants
2.2 ANSI/ASME Standard:
ANSI/ASME B46.1 Surface Texture (Surface Roughness, Waviness, and Lay)
2.3 ISO Standards:
ISO 5832-2 Implants for surgery—Metallic materials—Part 2: Unalloyed titanium
ISO 5832-3 Implants for surgery—Metallic materials—Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-4 Implants for surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloy
ISO 5832-5 Implants for surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel
ISO 5832-12 Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy
ISO 5834-2 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms
3. Terminology
3.1 Definitions:
3.1.1 carpal component—articulating member inserted into or through the carpal bones.
3.1.2 radial component—articulating member inserted into the radius for articulation with the carpal component.
3.1.3 total wrist replacement—prosthetic parts substituted for the native opposing radial and carpal articulating surfaces.
4. Classification
4.1 Constrained—A constrained joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more
than one anatomical plane and consists of either a single, flexible, across-the-joint component, or more than one component linked
together or affined.
4.2 Partially Constrained—A semi-constrained joint prosthesis is used for partial or total 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 linkages.
4.3 Unconstrained—An unconstrained joint prosthesis is used for partial or total joint replacement and restricts minimally
prosthesis movement in one or more planes. Its components have no across-the-joint linkages.
5. Materials and Manufacture
5.1 Proper material selection is necessary, but insufficient to ensure suitable functioning of a device.The choice of materials is
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F1357 − 23
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 and durability, corrosion resistance, and
biocompatibility.
5.2 All metal implant components shall conform to one of the following specifications for implant materials: ASTM Specification
Some examples of materials from which wrist replacement components have been successfully fabricated include Specifications
F67, F75, F90, F136, F562, F563 (nonbearing use only), F799, F1108, F1472or, F1537., ISO 5832-2, ISO 5832-3, ISO 5832-4,
ISO 5832-5, or ISO 5832-12. Polymeric bearing components have been fabricated from UHMWPE as specified in Specification
F648 or ISO 5834-2. Not all of these materials may possess sufficient mechanical strength for critical highly stressed components
nor for articulating surfaces.
5.3 All polymeric components shall conform to Specification F648 for implant materials.
5.4 All solid ceramic components shall conform to Specification F603 for implant materials.
5.3 Biocompatibility—Materials Devices made from materials with limited or no history of successful use for orthopedic implant
applicationapplications shall be determined to exhibit acceptable biological responses equal response when tested in accordance
with Practices F748, F981to or better than one of the , or ISO 10993-1. While no known surgical implant material has ever been
shown to be completely free of adverse reactions in the human body, long-term clinical experience has shown an acceptable level
of biological response can be expected if materials listed in 5.2 when tested are used. However, the specifications listed in 5.2 cover
raw materials and not finished medical devices, where the design and fabrication process of the device can impact biological
response. Hence, for devices made from material listed in 5.2, then its biocompatibility shall be verified in accordance with
Practices F748, F981and, F981.or ISO 10993-1, unless justification can be provided for why design and processing will not impact
the biocompatibility of the final, sterilized device.
5.4 Polymeric Component Oxidation Resistance—Polymeric components may be subject to degradation of mechanical or wear
performance due to oxidation and may need to be aged prior to subsequent mechanical testing following Practice F2003.
5.5 When required for metallic implants, fluorescent penetrant inspection shall be performed in accordance with Practice F601.
5.6 When required for cast metallic implants, radiography shall be performed in accordance with Practice F629.
5.7 Corrosion Resistance—Materials with limited or no history of successful use for orthopedic implant applicationapplications
shall be determined to exhibit corrosion resistance equal to or better than one of the materials listed in 5.2 when tested in
accordance with Test MethodMethods F746F2129 and F3306. The design and manufacturing process of the device can impact
corrosion resistance; therefore, testing shall be conducted on final devices in their final finished form. Substitute test articles may
be used for testing with adequate justification, if all processing steps, including sterilization and preconditioning, are comparable
to the finished device. If the corrosion resistance of a material is less than one of the materials listed in 5.2 when tested in
accordance with Test Methods F2129 and F3306, its use would need to be justified.
6. Performance Requirements
6.1 Polymeric Creep (Cold Flow)—Ultra-high-molecular-weight-polyethylene Ultra-high-molecular-weight polyethylene in
implant form shall conform to the requirements detailed in Specification F648. or ISO 5834-2. When creep occurs, it must not
impair the function or stability of the interface.
6.2 Wear of Alternative Materials—It is important to understand the wear performance for articulating surfaces. Any new or
different material couple should not exceed the wear rates of the following material couple when tested under physiological
conditions. The current standard wear couple that has demonstrated good clinical performance is CoCrMo alloy (Specification (see
Specification F75) against ultra-high-molecular-weight-polyethylene. This is an or ISO 5832-4) against UHMWPE (see
Specification F648 industry wide referenced or ISO 5834-2) both having prosthetic-quality finishes as described in 8.2wear couple
and is considered by some to be the minimum. It has been proven to provide clinically acceptable results. As implant design also
impacts wear performance, functional (simulated) wear tests of the implant shall be performed to evaluate wear performance and
results compared to a legally marketed reference implant.
F1357 − 23
NOTE 1—In situations where the pin-on-flat test may not be considered appropriate, other test methods may be considered.
6.3 Range of Motion of the Device Before Implantation—The implant shall be evaluated to determine the maximum dorsiflexion,
palmar extension, flexion, radial deviation, and ulnar deviation possible before subluxation occurs or the motion is arrested by the
implant. These results shallshould be reported in the product labeling. The necessary wrist motion needed for successful total wrist
replacement is not known, but it is suggested that total wrist replacement, before implantation, shall have at least the motion
available of clinically successful wrist arthroplasty devices.
6.4 Range of Motion of the Device After Implantation—The implant range of motion after implantation shall be measured in a
cadaver bone setting that includes soft tissue and ligamentous constraints. The cadavers selected shall have non-rheumatoid
arthritis joint degeneration, as cadavers with rheumatoid arthritis have stiffer joints which can limit the range of motion of the
device, thereby confounding the results. Implant motion can be measured as the motion of the long axis of the third metacarpal
relative to the long axis of the radius. Neutral flexion/extension
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