Recognized Consensus Standards: Medical Devices

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