Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

053

Date of Entry 12/23/2019

FR Recognition Number

8-520

Standard

ASTM F799-19
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Scope/Abstract

1.1 This specification covers requirements of cobalt-28 chromium-6 molybdenum alloy (UNS R31537, R31538, R31539) high-strength forgings for the manufacture of surgical implants. The properties specified in this document specifically apply to finished or semifinished parts that receive no subsequent thermomechanical processing.
1.2 Wrought material to be used as forging stock in the manufacture of forgings conforming to this specification, typically hot worked and unannealed with a surface finish suitable for forging, shall be fabricated and supplied in accordance with Specification F1537.

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)*

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