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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 11-324
Standard
ASTM  F366-17
Standard Specification for Fixation Pins and Wires
Scope/Abstract
1.1 This specification covers functional dimensions forfixation pins and wires.

1.2 In recognition of many broad and varied uses of suchpins and wires, many options are included. A variety, but notnecessarily all, of the options are illustrated in Figs. 1-3.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 KTT
§888.3040 Pin, Fixation, Smooth Class 2 HTY
§888.3040 Pin, Fixation, Threaded Class 2 JDW
Relevant FDA Guidance and/or Supportive Publications*
Reviewers Guidance Checklist for Orthopedic External Fixation Devices Version #5, 2/21/97

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Jonathan Peck
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/
  301-796-5650
  jonathan.peck@fda.hhs.gov
 Christopher Ferreira
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  301-796-9350
  christopher.ferreira@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
*These are provided as examples and others may be applicable.
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