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

11-329

Standard

ASTM F2180-17
Standard Specification for Metallic Implantable Strands and Cables

Scope/Abstract

1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties.

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
§888.3010	Cerclage, Fixation	Class 2	JDQ
§888.3010	Bone Fixation Cerclage, Sublaminar	Class 2	OWI

Relevant FDA Guidance and/or Supportive Publications*

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