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ASTM F1357-99(2009)

(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 (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
14-Jun-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
Current Stage
Ref Project

Relations

Replaces
ASTM F1357-99(2004) - Standard Specification for Articulating Total Wrist Implants
Effective Date
15-Jun-2009
Replaced By
ASTM F1357-09 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Aug-2009

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ASTM F1357-99(2009) - Standard Specification for Articulating Total Wrist ImplantsASTM F1357-99(2009) - Standard Specification for Articulating Total Wrist Implants
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ASTM F1357-99(2009) - Standard Specification for Articulating Total Wrist Implants
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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 2009)
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope Applications (UNS R30035)
F 563 Specification for Wrought Cobalt-20Nickel-
1.1 This specification describes total wrist implants, includ-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
ing solid ceramic implants, used to provide functioning articu-
for Surgical Implant Applications (UNS R30563)
lation by employing radial carpal components.
F 601 Practice for Fluorescent Penetrant Inspection of Me-
1.2 Thisspecificationexcludesthoseimplantswithceramic-
tallic Surgical Implants
coated or porous-coated surfaces, one piece elastomeric im-
F 603 Specification for High-Purity Dense Aluminum Ox-
plants (with or without grommets), and those devices used for
ide for Medical Application
custom applications.
F 629 Practice for Radiography of Cast Metallic Surgical
1.3 The values stated in SI units are to be regarded as
Implants
standard. No other units of measurement are included in this
F 648 Specification for Ultra-High-Molecular-Weight Poly-
standard.
ethylene Powder and Fabricated Form for Surgical Im-
1.4 This standard does not purport to address all of the
plants
safety concerns, if any, associated with its use. It is the
F 748 Practice for Selecting Generic Biological Test Meth-
responsibility of the user of this standard to establish appro-
ods for Materials and Devices
priate safety and health practices and determine the applica-
F 799 SpecificationforCobalt-28Chromium-6Molybdenum
bility of regulatory limitations prior to use.
Alloy Forgings for Surgical Implants (UNS R31537,
2. Referenced Documents R31538, R31539)
F 981 Practice for Assessment of Compatibility of Bioma-
2.1 ASTM Standards:
terials for Surgical Implants with Respect to Effect of
F67 Specification for Unalloyed Titanium, for Surgical
Materials on Muscle and Bone
Implant Applications (UNS R50250, UNS R50400, UNS
F 983 Practice for Permanent Marking of Orthopaedic Im-
R50550, UNS R50700)
plant Components
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
F 1108 Specification for Titanium-6Aluminum-4Vanadium
Alloy Castings and Casting Alloy for Surgical Implants
Alloy Castings for Surgical Implants (UNS R56406)
(UNS R30075)
F 1537 Specification for Wrought Cobalt-28Chromium-
F86 Practice for Surface Preparation and Marking of Me-
6MolybdenumAlloysforSurgicalImplants(UNSR31537,
tallic Surgical Implants
UNS R31538, and UNS R31539)
F90 Specification for Wrought Cobalt-20Chromium-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
3. Terminology
tions (UNS R30605)
3.1 Definitions:
F 136 Specification for Wrought Titanium-6Aluminum-
3.1.1 carpal component—articulating member inserted into
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
or through the carpal bones.
Implant Applications (UNS R56401)
3.1.2 radial component—articulating member inserted into
F 562 Specification for Wrought 35Cobalt-35Nickel-
the radius for articulation with the carpal component.
20Chromium-10Molybdenum Alloy for Surgical Implant
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 4. Classification
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1 Constrained—A constrained joint prosthesis is used for
Subcommittee F04.22 on Arthroplasty.
joint replacement and prevents dislocation of the prosthesis in
Current edition approved June 15, 2009. Published July 2009. Originally
approved in 1991. Last previous edition approved in 2004 as F 1357 - 99 (2004).
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 Withdrawn. The last approved version of this historical standard is referenced
the ASTM website. on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1357 – 99 (2009)
more than one anatomical plane and consists of either a single, tion possible before subluxation occurs or the motion is
flexible, across-the-joint component, or more than one compo- arrested by the implant. These results shall be reported in the
nent linked together or affined. product labeling.
6.4 Guidelines for In-Vitro Laboratory Testing—No ASTM
4.2 Partially Constrained—A semi-constrained joint pros-
standards for testing articulating wrist implants have not been
thesis is used for partial or total joint replacement and limits
developed. Laboratory testing that simulates the conditions of
translation and rotation of the prosthesis in one or more planes
use is desirable to compare materials and designs and to
via the geometry of its articulating surfaces. It has no across-
provide an indication of clinical performance. Implant testing
the-joint linkages.
shall be done in keeping with the implants intended function,
4.3 Unconstrained—An unconstrained joint prosthesis is
that is, implants intended to partially stabilize or stabilize a
used for partial or total joint replacement and restricts mini-
joint shall be subjected to the maximum destabilizing force
mally prosthesis movement in one or more planes. Its compo-
anticipated in clinical application during flexural testing.
nents have no across-the-joint linkages.
7. Dimensions
5. Materials and Manufacture
7.1 Dimensions of wrist joint replacement components shall
5.1 Proper material selection is necessary, but insufficient to
be as designated in Figs. 1 and 2.
ensure suitable function of a device.
5.2 All metal implant components shall conform to one of
8. Finish and Marking
the following specifications for implant materials: Specifica-
8.1 Items conforming to this specification shall be finished
tion F67, F75, F90, F 136, F 562, F 563 (nonbearing use
andmarkedinaccordancewithPracticeF86whereapplicable.
only), F 799, F 1108,or F 1537.
8.2 Metallic Bearing Surface—Articulate surfaces shall be
5.3 All polymeric components shall conform to the follow-
finished to an average roughness of 0.125 µm.
ing specification for implant materials: Specification F 648.
8.3 Polymeric Bearing Surface Finish— shall conform to
5.4 All solid ceramic components shall conform to Specifi-
manufacturer’s documented standards concerning concentric-
cation F 603 for implant materials.
ity, sphericity, and surface roughness, when applicable.
5.5 Biocompatibility—Articulating implants shall be manu-
8.4 Items conforming to this specification shall be marked
factured from the materials listed in 5.2-5.4. Before implants
in accordance with PracticesF86 and F 983. Radial and carpal
can be manufactured from other materials, their biocompatibil-
component marking shall include, as possible, the items below
ity will be considered suitable only if they produce an
in the following order of importance:
acceptable response after testing in accordance with Practice
8.4.1 Manufacturer,
F 981.
8.4.2 Size,
5.6 When required for metallic implants, fluorescent pen- 8.4.3 Catalog Number,
etrant inspection shall be performed in accordance with Prac- 8.4.4 Lot Number, and
tice F 601.
5.7 When required for cast metallic implants, radiography
shall be performed in accordance with Practice F 629.
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 F75) 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 t
...

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ASTM
ASTM F3140-23(Test Method)
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

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