ASTM F2180-02 (Reapproved 2015)

Standard Organization:

ASTM F2180-02 (Reapproved 2015)
Standard Specification for Metallic Implantable Strands and Cables

• Recognition Date: 2016-06-27
• Recognition List: 043
• Recognition Number: 11-271
• Extent: Complete standard
• Standards Orgs: ASTM ASTM International http://www.astm.org/
• STG: Orthopedic
• FDA Tech: Jonathan Peck FDA/OMPT/CDRH/ODE/DOD/PSDB/ 301-796-5650 jonathan.peck@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§888.3010	Bone Fixation Cerclage, Sublaminar	Class 2	OWI
§888.3010	Cerclage, Fixation	Class 2	JDQ

FDA Guidance:

There is no relevant guidance developed at this time.