ASTM F1377-13

Standard Organization:

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

Recognition Date2014-01-30
Recognition List034
Recognition Number8-354
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Materials
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

There is no relevant guidance developed at this time.

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