ASTM F366-17

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.
FIG. 1 Fixation Pins and Wires  
Note 1: Pins and wires may be smooth shank or threaded.  
Note 2: Point angle and helix angle, where applicable, is as specified by the 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 3.2 mm may be reduced.  
Note 4: Optional designs, both ends pointed or point with suture hole.  
FIG. 2 Fixation Pin-Knowles Type  
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 the intended medical application.  
Note 4: Optional marking in this location.  
FIG. 3 Fixation Pin-Hagie 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 the intended medical application.  
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 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.

General Information

• Status: Historical
• Publication Date: 31-Aug-2017
• ICS: 21.060.60 - Rings, bushes, sleeves, collars
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F366-10(2015) - Standard Specification for Fixation Pins and Wires
• Effective Date: 01-Sep-2017
• Refers: ASTM F2503-23e1 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 01-Apr-2023
• Refers: ASTM F2503-13 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 01-Jun-2013
• Refers: ASTM F86-12a - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Dec-2012
• Refers: ASTM F86-12 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 15-May-2012
• Refers: ASTM F86-04(2009) - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Dec-2009
• Refers: ASTM F2503-08 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 01-Oct-2008
• Refers: ASTM F2503-05 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• Effective Date: 01-Aug-2005
• Refers: ASTM F86-04 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 01-Oct-2004
• Refers: ASTM F86-00 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 10-Jan-2001
• Refers: ASTM F86-01 - Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
• Effective Date: 10-Jan-2001
• Referred By: ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
• Effective Date: 01-Sep-2017

Standards Content (Sample)

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.
Designation: F366 −17
Standard Specification for
1
Fixation Pins and Wires
ThisstandardisissuedunderthefixeddesignationF366;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope materials shall be biocompatible for the intended application.
Materials should be chosen based on the design requirements
1.1 This specification covers functional dimensions for
of the particular device. ASTM committee F04.12 maintains a
fixation pins and wires.
number of specifications for materials that are suitable for
1.2 In recognition of many broad and varied uses of such
surgical implant applications.
pins and wires, many options are included. A variety, but not
necessarily all, of the options are illustrated in Figs. 1-3.
4. Performance Requirements
1.3 The values stated in SI units are to be regarded as
4.1 Factors considered to be important, but for which values
standard. No other units of measurement are included in this
and test methods have not been established, are bending
standard.
strength, fatigue strength, breaking strength (Knowles Type
only), torsion strength, and ductility.
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
5. Dimensions and Characteristics
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 5.1 Fixationpinsandwiresshallbefabricatedinaccordance
mendations issued by the World Trade Organization Technical
with the dimensions illustrated in Figs. 1-4.
Barriers to Trade (TBT) Committee.
5.2 Fixation pins and wires shall have surfaces prepared and
marked in accordance with Practice F86.
2. Referenced Documents
5.2.1 Optional marking on the fixation pins and wires shall
2
2.1 ASTM Standards:
identify the manufacturer or distributor.
F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
6. Packaging and Labeling
F368 Specification for Fixation Pins-Knowles and Hagie
3 6.1 Packaging shall be adequate to protect the fixation pins
Types (Withdrawn 1982)
and wires during shipment.
F2503 Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance Environment 6.2 Labeling for fixation pins and wires shall include:
6.2.1 Product name,
3. Materials
6.2.2 Size, on the immediate container,
3.1 Fixationpinsshallbefabricatedfromametallicmaterial
6.2.2.1 Length,
intended for surgical implant applications. In addition, the
6.2.2.2 Diameter (if round) or cross-sectional size (if square
or hexagonal), that is, 6.4 mm square, and
1
This specification is under the jurisdiction of ASTM Committee F04 on
6.2.3 ASTM material specification Designation number.
Medical and Surgical Materials and Devices and is the direct responsibility of
6.3 Consider Practice F2503 to identify potential hazards
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Sept. 1, 2017. Published October 2017. Originally
produced by interactions between the device and the MR
approved in 1973. Last previous edition approved in 2010 as F366 – 10 (2015).
environment and for terms that may be used to label the device
DOI: 10.1520/F0366-17.
2 for safety in the MR environment.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on 7. Keywords
the ASTM website.
3
7.1 fixation materials; flexible surgical wire; orthopaedic
The last approved version of this historical standard is referenced on
www.astm.org. medical devices; wire-surgical implants
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F366 − 17
NOTE 1—Pins and wires may be smooth shank or threaded.
NOTE 2—Point angle and helix angle, where applicable, is as specified by the 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 3.2 mm may be reduced.
NOTE 4—Optional designs, both ends pointed or point with suture hole.
FIG. 1 Fixation Pins and Wires
2

---------------------- Page: 2 ----------------------
F366 − 17
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 larg
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: F366 − 10 (Reapproved 2015) F366 − 17
Standard Specification for
1
Fixation Pins and Wires
This standard is issued under the fixed designation F366; 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 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 SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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
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)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
3
F368 Specification for Fixation Pins-Knowles and Hagie Types (Withdrawn 1982)
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
3
Applications (UNS R30563) (Withdrawn 2005)
F1314 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)
F1537F2503 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance
Environment
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless
Steel Alloy Bar for Surgical Implants (UNS S31675)
3. Materials
3.1 Fixation pins and wires shall be fabricated from material conforming to one of the following ASTM Specifications:a metallic
material intended for surgical implant applications. In addition, the materials shall be biocompatible for the intended application.
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
F04.21 on Osteosynthesis.
Current edition approved March 1, 2015Sept. 1, 2017. Published April 2015October 2017. Originally approved in 1973. Last previous edition approved in 2010 as
F366 – 10.F366 – 10 (2015). DOI: 10.1520/F0366-10R15. 10.1520/F0366-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F366 − 17
NOTE 1—Pins and wires may be smooth shank or threaded.
NOTE 2—Point angle and helix angle, where applicable, is as specified by the 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 3.2 mm may be reduced.
NOTE 4—Optional designs, both ends pointed or point with suture hole.
FIG. 1 Fixation Pins and Wires
Materials should be chosen based on the design requ
...