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ASTM F1357-99(2004)

(Specification)

Standard Specification for Articulating Total Wrist Implants

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 carpal components.
1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one piece elastomeric implants, and those devices used for custom applications.
1.3 The values stated in SI units are standard. The English values in parentheses are for information only.

General Information

Status
Historical
Publication Date
31-Mar-2004
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F1357-99 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Apr-2004
Replaced By
ASTM F1357-99(2009) - Standard Specification for Articulating Total Wrist Implants
Effective Date
15-Jun-2009

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ASTM F1357-99(2004) - Standard Specification for Articulating Total Wrist ImplantsASTM F1357-99(2004) - Standard Specification for Articulating Total Wrist Implants
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ASTM F1357-99(2004) - Standard Specification for Articulating Total Wrist Implants
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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: F 1357 – 99 (Reapproved 2004)
Standard Specification for
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope for Surgical Implant Applications (UNS R30563)
F 601 Practice for Fluorescent Penetrant Inspection of Me-
1.1 This specification describes total wrist implants, includ-
tallic Surgical Implants
ing solid ceramic implants, used to provide functioning articu-
F 603 Specification for High-Purity Dense Aluminum Ox-
lation by employing radial carpal components.
ide for Medical Application
1.2 Thisspecificationexcludesthoseimplantswithceramic-
F 629 Practice for Radiography of Cast Metallic Surgical
coated or porous-coated surfaces, one piece elastomeric im-
Implants
plants (with or without grommets), and those devices used for
F 648 Specification for Ultra-High-Molecular-Weight Poly-
custom applications.
ethylene Powder and Fabricated Form for Surgical Im-
1.3 The values stated in SI units are standard. The English
plants
values in parentheses are for information only.
F 748 Practice for Selecting Generic Biological Test Meth-
2. Referenced Documents ods for Materials and Devices
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
2.1 ASTM Standards:
Alloy Forgings for Surgical Implants (UNS R31537,
F 67 Specification for Unalloyed Titanium, for Surgical
R31538, R31539)
Implant Applications, (UNS R50250, UNS R50550, UNS
F 981 Practice for Assessment of Compatibility of Bioma-
R50700)
terials for Surgical Implants with Respect to Effect of
F 75 Specification for Cobalt-28Chromium-6Molybdenum
Materials on Muscle and Bone
Alloy Castings and Casting Alloy for Surgical Implants
F 983 Practice for Permanent Marking of Orthopaedic Im-
(UNS R30075)
plant Components
F 86 Practice for Surface Preparation and Marking of Me-
F 1108 Specification for Titanium-6Aluminum-4Vanadium
tallic Surgical Implants
Alloy Castings for Surgical Implants (UNS R56406)
F 90 Specification for Wrought Cobalt-20Chromium-
F 1537 Specification for Wrought Cobalt-28Chromium-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
6MolybdenumAlloysforSurgicalImplants(UNSR31537,
tions (UNS R30605)
UNS R31538, and UNS R31539)
F 136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
3. Terminology
Implant Applications (UNS R56401)
3.1 Definitions:
F 562 Specification for Wrought 35Cobalt-35Nickel-
3.1.1 carpal component—articulating member inserted into
20Chromium-10Molybdenum Alloy for Surgical Implant
or through the carpal bones.
Applications (UNS R30035)
3.1.2 radial component—articulating member inserted into
F 563 Specification for Wrought Cobalt-20Nickel-
the radius for articulation with the carpal component.
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
3.1.3 total wrist replacement—prosthetic parts substituted
for the native opposing radial and carpal articulating surfaces.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
4. Classification
Subcommittee F04.22 on Arthroplasty.
4.1 Constrained—A constrained joint prosthesis is used for
Current edition approved Apr. 1, 2004. Published April 2004. Originally
approved in 1991. Last previous edition approved in 1999 as F 1357 - 99.
joint replacement and prevents dislocation of the prosthesis in
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
more than one anatomical plane and consists of either a single,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
flexible, across-the-joint component, or more than one compo-
Standards volume information, refer to the standard’s Document Summary page on
nent linked together or affined.
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1357 – 99 (2004)
4.2 Partially Constrained—A semi-constrained joint pros- developed. Laboratory testing that simulates the conditions of
thesis is used for partial or total joint replacement and limits use is desirable to compare materials and designs and to
translation and rotation of the prosthesis in one or more planes provide an indication of clinical performance. Implant testing
via the geometry of its articulating surfaces. It has no across- shall be done in keeping with the implants intended function,
the-joint linkages. that is, implants intended to partially stabilize or stabilize a
4.3 Unconstrained—An unconstrained joint prosthesis is joint shall be subjected to the maximum destabilizing force
used for partial or total joint replacement and restricts mini- anticipated in clinical application during flexural testing.
mally prosthesis movement in one or more planes. Its compo-
7. Dimensions
nents have no across-the-joint linkages.
7.1 Dimensions of wrist joint replacement components shall
5. Materials and Manufacture
be as designated in Figs. 1 and 2.
5.1 Proper material selection is necessary, but insufficient to
8. Finish and Marking
ensure suitable function of a device.
8.1 Items conforming to this specification shall be finished
5.2 All metal implant components shall conform to one of
andmarkedinaccordancewithPracticeF 86whereapplicable.
the following specifications for implant materials: Specifica-
8.2 Metallic Bearing Surface—Articulate surfaces shall be
tion F 67, F 75, F 90, F 136, F 562, F 563 (nonbearing use
finished to an average roughness of 0.125 µm.
only), F 799, F 1108, or F 1537.
8.3 Polymeric Bearing Surface Finish— shall conform to
5.3 All polymeric components shall conform to the follow-
manufacturer’s documented standards concerning concentric-
ing specification for implant materials: Specification F 648.
ity, sphericity, and surface roughness, when applicable.
5.4 All solid ceramic components shall conform to Specifi-
8.4 Items conforming to this specification shall be marked
cation F 603 for implant materials.
in accordance with Practices F 86 and F 983. Radial and carpal
5.5 Biocompatibility—Articulating implants shall be manu-
component marking shall include, as possible, the items below
factured from the materials listed in 5.2-5.4. Before implants
in the following order of importance:
can be manufactured from other materials, their biocompatibil-
8.4.1 Manufacturer,
ity will be considered suitable only if they produce an
8.4.2 Size,
acceptable response after testing in accordance with Practice
8.4.3 Catalog Number,
F 981.
8.4.4 Lot Number, and
5.6 When required for metallic implants, fluorescent pen-
8.4.5 Orientation (dorsal/palmar/radial/ulnar/left/right as
etrant inspection shall be performed in accordance with Prac-
appropriate).
tice F 601.
8.5 If one of the components is not radiographic opaque, it
5.7 When required for cast metallic implants, radiography
shall contain a marker wire or other means of radiographic
shall be performed in accordance with Practice F 629.
detection. If used, it may be located at the manufacturer’s
discretion.
6. Performance Requirements
6.1 Polymeric Creep (Cold Flow)—Ultra-high molecular
weight polyethylene in implant form must conform to the
requirements detailed in Specification F 648. When creep
occurs, it must not impair the function or stability of the
interface.
6.2 Wear of Alternative Materials—It is important to under-
stand 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 wear couple is CoCrMo alloy (Speci-
fication F 75) against ultra high molecular weight polyethyl-
ene. This is an industry wide referenced wear couple and is
considered by some to be the minimum. It has been proven to
provide clinically acceptable results.
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 flexion, radial deviation, and ulnar devia-
tion possible before subluxation occurs or the motion is
arrested by the implant. These results shall be reported in the
product
...

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SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.  
4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions.  
4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.  
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.  
1.3 This test method may require modifications to accommodate other tibial tray designs.  
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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.

  • Standard
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  • Standard
    6 pages
    English language
    sale 15% off