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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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.
Transition Period
FDA recognition of ASTM F1377-13 [Rec# 8-354] will be superseded by recognition of ASTM F1377-21 [Rec# 8-585]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-354] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 8-354] will not be accepted.
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
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
 Michael J. Ryan
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-6283
  michael.ryan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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