ASTM F1357-09

Standard Specification for Articulating Total Wrist Implants

ABSTRACT
This specification covers total wrist implants that provide articulation function through radial carpal components. However, this specification does not include implants with ceramic coated or porous coated surfaces, one-piece elastomeric implants, and those used for custom applications. Implants covered by this specification are of the constrained, partially constrained, or unconstrained joint prosthesis type. The implants shall be manufactured from biocompatible materials made of unalloyed titanium, cobalt-28chromium-6molybdenum alloy, wrought cobalt-20chromium-15tungsten-10nickel alloy, wrought titanium-6aluminum-4vanadium extra low interstitial alloy, wrought 35cobalt-35nickel-20chromium-10molybdenum alloy, wrought cobalt-20nickel-20chromium-3.5molybdenum-3.5tungsten-5iron alloy, cobalt-28chromium-6molybdenum alloy, titanium-6aluminum-4vanadium alloy, or wrought cobalt-28chromium-6molybdenum alloy with dimensions in conformity to the requirements specified. Tests for polymeric creep (cold flow), wear, and range of motion of the device as well as in vitro laboratory testing shall be performed and shall conform to the requirements specified. Per service requirement, metallic implants shall undergo fluorescent penetrant inspection, while cast metallic implants shall undergo radiography.
SCOPE
1.1 This specification describes total wrist implants, including solid ceramic 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Jul-2009
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Replaces: ASTM F1357-99(2009) - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Aug-2009
• Replaced By: ASTM F1357-14 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 15-Nov-2014

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:F1357 −09
StandardSpecification for
1
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 F562 Specification for Wrought 35Cobalt-35Nickel-
20Chromium-10Molybdenum Alloy for Surgical Implant
1.1 This specification describes total wrist implants, includ-
Applications (UNS R30035)
ing solid ceramic implants, used to provide functioning articu-
F563 Specification for Wrought Cobalt-20Nickel-
lation by employing radial and carpal components.
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.2 Thisspecificationexcludesthoseimplantswithceramic-
for Surgical Implant Applications (UNS R30563) (With-
coated or porous-coated surfaces, one-piece elastomeric im- 3
drawn 2005)
plants (with or without grommets), and those devices used for
F601 Practice for Fluorescent Penetrant Inspection of Me-
custom applications.
tallic Surgical Implants
F603 Specification for High-Purity Dense Aluminum Oxide
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this for Medical Application
F629 Practice for Radiography of Cast Metallic Surgical
standard.
Implants
1.4 This standard does not purport to address all of the
F648 Specification for Ultra-High-Molecular-Weight Poly-
safety concerns, if any, associated with its use. It is the
ethylene Powder and Fabricated Form for Surgical Im-
responsibility of the user of this standard to establish appro-
plants
priate safety and health practices and determine the applica-
F748 PracticeforSelectingGenericBiologicalTestMethods
bility of regulatory limitations prior to use.
for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum
2. Referenced Documents
Alloy Forgings for Surgical Implants (UNS R31537,
2
2.1 ASTM Standards:
R31538, R31539)
F67 Specification for Unalloyed Titanium, for Surgical Im-
F981 Practice for Assessment of Compatibility of Biomate-
plant Applications (UNS R50250, UNS R50400, UNS
rials for Surgical Implants with Respect to Effect of
R50550, UNS R50700)
Materials on Muscle and Bone
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F983 Practice for Permanent Marking of Orthopaedic Im-
Alloy Castings and Casting Alloy for Surgical Implants
plant Components
(UNS R30075)
F1108 Specification for Titanium-6Aluminum-4Vanadium
F86 Practice for Surface Preparation and Marking of Metal-
Alloy Castings for Surgical Implants (UNS R56406)
lic Surgical Implants
F1537 Specification for Wrought Cobalt-28Chromium-
F90 Specification for Wrought Cobalt-20Chromium-
6Molybdenum Alloys for Surgical Implants (UNS
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
R31537, UNS R31538, and UNS R31539)
tions (UNS R30605)
2.2 ANSI/ASME Standard:
F136 Specification for Wrought Titanium-6Aluminum-
ANSI/ASME B46.1 Surface Texture (Surface Roughness,
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
4
Waviness, and Lay)
Implant Applications (UNS R56401)
3. Terminology
1
This specification is under the jurisdiction of ASTM Committee F04 on 3.1 Definitions:
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1.1 carpal component—articulating member inserted into
Subcommittee F04.22 on Arthroplasty.
or through the carpal bones.
Current edition approved Aug. 1, 2009. Published August 2009. Originally
approved in 1991. Last previous edition approved in 2009 as F1357 – 99 (2009).
DOI: 10.1520/F1357-09.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM www.astm.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1357−09
3.1.2 radial component—articulating member inserted into This is an industry wide referenced wear couple and is
the radius for articulation with the carpal component. considered by some to be the minimum. It has been proven to
provide clinically acceptable results.
3.1.3 total wrist replacement—prosthetic parts substituted
for the native opposing radial and carpal articulating surfaces.
NOTE 1—In situations where the pin-on-flat test may not be consider
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1357–99 (Reapproved2009) Designation: F 1357 – 09
Standard Specification for
1
Articulating Total Wrist Implants
This standard is issued under the fixed designation F 1357; 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, 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F67 SpecificationforUnalloyedTitanium,forSurgicalImplantApplications(UNSR50250,UNSR50400,UNSR50550,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)
F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F 562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F 563 SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5IronAlloyforSurgicalImplant
Applications (UNS R30563)
F 601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F 603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F 629 Practice for Radiography of Cast Metallic Surgical Implants
F 648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F 799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F 983 Practice for Permanent Marking of Orthopaedic Implant Components
F 1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F 1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
2.2 ANSI/ASME Standard:
1
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 June 15,Aug. 1, 2009. Published JulyAugust 2009. Originally approved in 1991. Last previous edition approved in 20042009 as F1357-99
(2004).F 1357 – 99 (2009).
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
1

---------------------- Page: 1 ----------------------
F1357–09
3
ANSI/ASME B46.1 Surface Texture (Surface Roughness, Waviness, and Lay)
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—Aconstrained joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more
than one an
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F 1357–99 (Reapproved2009) Designation: F1357 – 09
Standard Specification for
1
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, 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F67 Specification for UnalloyedTitanium, for Surgical ImplantApplications (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-5IronAlloy for Surgical Implant
Applications (UNS R30563)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
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
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum 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 Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
2.2 ANSI/ASME Standard:
1
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 June 15, 2009. Published July 2009. Originally approved in 1991. Last previous edition approved in 2004 as F 1357-99 (2004).
Current edition approved Aug. 1, 2009. Published August 2009. Originally approved in 1991. Last previous edition approved in 2009 as F1357 – 99 (2009). DOI:
10.1520/F1357-09.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
1

---------------------- Page: 1 ----------------------
F1357 – 09
3
ANSI/ASME B46.1 Surface Texture (Surface Roughness, Waviness, and Lay)
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. Classi
...