ASTM F366-04(2009)
(Specification)Standard Specification for Fixation Pins and Wires
Standard Specification for Fixation Pins and Wires
ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.
1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
Note 1—Pins and wires may be smooth shank or threaded.
Note 2—Point angle and helix angle, where applicable, is as specified by manufacturer.
Note 3—On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger than 1/8 in. (3.2 mm) may be reduced.
Note 4—Optional designs, both ends pointed or point with suture hole. FIG. 1 Fixation Pins and Wires
Note 1—Shall be made of one piece of material; that is, not an assembly of two or more pieces.
Note 2—Thread major diameter may be the same or larger than the shaft diameter.
Note 3—Thread length shall be optional to suit intended medical application.
Note 4—Optional marking in this location. FIG. 2 Fixation Pin-Knowles Type
Note 1—Thread major diameter may be the same or larger than the shaft diameter.
Note 2—Thread length shall be optional to suit intended medical application. FIG. 3 Fixation Pin-Hagie Type
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Designation: F366 – 04 (Reapproved 2009)
Standard Specification for
Fixation Pins and Wires
ThisstandardisissuedunderthefixeddesignationF366;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope F563 Specification for Wrought Cobalt-20Nickel-
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.1 This specification covers functional dimensions for
for Surgical Implant Applications (UNS R30563)
fixation pins and wires.
F1314 Specification for Wrought Nitrogen Strengthened 22
1.2 In recognition of many broad and varied uses of such
Chromium−13Nickel−5Manganese−2.5Molybdenum
pins and wires, many options are included. A variety, but not
Stainless Steel Alloy Bar and Wire for Surgical Implants
necessarily all, of the options are illustrated in Figs. 1-3.
(UNS S20910)
1.3 The values stated in inch-pound units are to be regarded
F1537 Specification for Wrought Cobalt-28Chromium-
as standard. The values given in parentheses are mathematical
6MolybdenumAlloysforSurgicalImplants(UNSR31537,
conversions to SI units that are provided for information only
UNS R31538, and UNS R31539)
and are not considered standard.
F1586 Specification for Wrought Nitrogen Strengthened
2. Referenced Documents 21Chromium—10Nickel—3Manganese—
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
2.1 ASTM Standards:
Implants (UNS S31675)
F67 Specification for Unalloyed Titanium, for Surgical
Implant Applications (UNS R50250, UNS R50400, UNS
3. Materials
R50550, UNS R50700)
3.1 Fixationpinsandwiresshallbefabricatedfrommaterial
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
conformingtooneofthefollowingASTMSpecifications:F67,
Alloy Castings and Casting Alloy for Surgical Implants
F75, F90, F136, F138, F562, F563, F1314, F1537, and F1586.
(UNS R30075)
F86 Practice for Surface Preparation and Marking of Me-
4. Performance Requirements
tallic Surgical Implants
4.1 Factorsconsideredtobeimportant,butforwhichvalues
F90 Specification for Wrought Cobalt-20Chromium-
and test methods have not been established, are bending
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
strength, fatigue strength, breaking strength (Knowles Type
tions (UNS R30605)
only), torsion strength, and ductility.
F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
5. Dimensions and Characteristics
Implant Applications (UNS R56401)
5.1 Fixationpinsandwiresshallbefabricatedinaccordance
F138 Specification for Wrought 18Chromium-14Nickel-
with the dimensions illustrated in Figs. 1-4.
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
5.2 Fixationpinsandwiresshallhavesurfacespreparedand
Implants (UNS S31673)
marked in accordance with Practice F86.
F562 Specification for Wrought 35Cobalt-35Nickel-
5.2.1 Optional marking on the fixation pins and wires shall
20Chromium-10Molybdenum Alloy for Surgical Implant
identify the manufacturer or distributor.
Applications (UNS R30035)
6. Packaging and Labeling
6.1 Packaging shall be adequate to protect the fixation pins
This specification is under the jurisdiction of ASTM Committee F04 on
and wires during shipment.
Medical and Surgical Materials and Devices and is the direct responsibility of
6.2 Labeling for fixation pins and wires shall include:
Subcommittee F04.21 on Osteosynthesis.
6.2.1 Product name,
Current edition approved April 1, 2009. Published April 2009. Originally
approved in 1973. Last previous edition approved in 2004 as F366–04. DOI:
6.2.2 Size, on the immediate container,
10.1520/F0366-04R09.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of
...
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.
´1
Designation:F366 – 82 (Reapproved 1993) Designation: F 366 – 04 (Reapproved 2009)
Standard Specification for
Fixation Pins and Wires
This standard is issued under the fixed designation F 366; 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.
This standard has been approved for use by agencies of the Department of Defense.
´ NOTE—Section 7 was added editorially in May 1993.
1. Scope
1.1 This specification covers functional dimensions for fixation pins and wires.
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not
necessarily all, of the options are illustrated in Figs. 1-3.
1.3The values stated in inch-pound units are to be regarded as the standard.
1.4The values given in parentheses are provided for information only.
1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2.1 ASTM Standards:F55Specification for Stainless Steel Bar and Wire for Surgical Implants
F67 Specification for UnalloyedTitanium for Surgical ImplantApplications Specification for UnalloyedTitanium, 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)
F 136 Specification for Wrought Titanium 6A1-4V ELI Alloy for Surgical Implant Applications Specification for Wrought
Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
F 138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(Special Quality) (UNS S31673)
F 562 Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications
Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS
R30035)
F 563 Specification for Wrought Cobalt-Nickel-Chromium-Molybdenum-Tungsten-Iron Alloy for Surgical Implant Applica-
tions Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Im-
plant Applications (UNS R30563)
F 1314 Specification for Wrought Nitrogen Strengthened 22 Chromium 13 Nickel 5 Manganese 2.5 Molybdenum Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F 1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
F 1586 Specification for Wrought Nitrogen Strengthened 21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel
Alloy Bar for Surgical Implants (UNS S31675)
This specification is under the jurisdiction of ASTM Committee F-4F04 on Medical and Surgical Materials and Devices,Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Aug. 27, 1982. Published February 1983. Originally published as F366-73. Last previous edition F366-73.
Current edition approved April 1, 2009. Published April 2009. Originally approved in 1973. Last previous edition approved in 2004 as F 366 – 04.
Discontinued—See 1991
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 13.01.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.
F 366 – 04 (2009)
NOTE 1—Pins and wires may be smooth shank or threaded.
NOTE 2—Point angle a
...
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