Recognized Consensus Standards

Recognition List Number: 022 Publication Date: 09/08/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-175: ASTM F1377-08, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075). (Materials)

Date of Standard: 2008. 

Address of Standards Organization:

  ASTM International (ASTM)

  100 Barr Harbor Drive

  West Conshohocken, PA 19428-2959

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)

(2)	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Metallic Porous Coatings on Implants

Processes Affected:

510(K), IDE, PMA, PDP, HDE, Design Controls

Type of Standard:

 National, Horizontal

Extent of Recognition:

Complete Standard
Standard covers materials characterization and biocompatibility. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. In applications subjected to wear or articulation, additional data must be provided to document resistance to wear and abrasion.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class 3	MBD
Regulation Number	Device Name	Device Class	Product Code
§872.3640	Implant, Endosseous, Root-Form	Class 2	DZE
Regulation Number	Device Name	Device Class	Product Code
§872.3940	Joint, Temporomandibular, Implant	Class 3	LZD
Regulation Number	Device Name	Device Class	Product Code
§872.3950	Glenoid Fossa Prosthesis	Class 3	MPI
Regulation Number	Device Name	Device Class	Product Code
§872.3960	Mandibular Condyle Prosthesis	Class 3	MPL
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
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

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contacts:

David M. Saylor   FDA/CDRH/OSEL   10903 New Hampshire Avenue Buildidng 62, Room 3082   Silver Spring MD 20993   301/796-2626   Email: david.saylor@fda.hhs.gov

Michael J. Ryan (Dental)   FDA/CDRH/ODE   10903 New Hampshire Avenue Building 66, Room 1615   Silver Spring MD 20993   301/796-6283   Email: michael.ryan@fda.hhs.gov