Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

065

Date of Entry 12/22/2025

FR Recognition Number

8-639

Standard

ASTM F1091-25
Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)

Scope/Abstract

This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought cobalt-20chromium-15tungsten-10nickel surgical fixation wire.

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.

Transition Period

FDA recognition of ASTM F1091-20 [Rec# 8-540] will be superseded by recognition of ASTM F1091-25 [Rec# 8-639]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-540] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-540] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Implantable Medical Devices

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

David M. Saylor

FDA/OC/CDRH/OSEL/DBCMS/

301-796-2626

david.saylor@fda.hhs.gov

Matthew Di Prima

FDA/OC/CDRH/OSEL/DAM/

301-796-2507

matthew.diprima@fda.hhs.gov

Standards Development Organization

ASTM

ASTM International