Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Entry 01/30/2014

FR Recognition Number

8-354

Standard

ASTM F1377-13 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

Scope/Abstract

1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating coatings on cobalt-28chromium-6molybdenum alloy orthopedic implants.

1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.

1.3 This specification covers powder requirements only. It does not address properties of the coatings formed from them.

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
§888.3358	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class 2	LPH
§888.3358	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class 2	MBL
§872.3640	Implant, Endosseous, Root-Form	Class 2	DZE
§872.3940	Joint, Temporomandibular, Implant	Class 3	LZD
§872.3950	Glenoid Fossa Prosthesis	Class 3	MPI
§872.3960	Mandibular Condyle Prosthesis	Class 3	MPL

Unclassified	Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class 3	MBD
§888.3565	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class 2	MBH