• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 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
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§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
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
Unclassified Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 3 MBD
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 David M. Saylor
  FDA/OMPT/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
 Michael J. Ryan
  FDA/OMPT/CDRH/ODE/DAGID/
  301-796-6283
  michael.ryan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
-
-