Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-111: ASTM F1160-05 (Reapproved 2011), Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings. (Materials)

Date of Standard: 2005. 

Address of Standards Organization:

  ASTM International (ASTM)

  100 Barr Harbor Drive

  West Conshohocken, PA 19428-2959

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Porous Coated Devices

Processes Affected:

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

Type of Standard:

 Test Methods, National, Horizontal

Extent of Recognition:

Complete standard.
Method of generating data on mechanical properties of coating. Additional testing may be necessary to fully characterize the coating.

Related CFR Citations and Product Codes:

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:

Guidance Document for Testing Orthopaedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement, April 28, 1994

FDA Technical Contacts:

Terry O. Woods   FDA/CDRH/OSEL   10903 New Hampshire Avenue Building 62, Room 2116   Silver Spring MD 20993   301/796-2503   Email: terry.woods@fda.hhs.gov

Peter Allen   FDA/CDRH/ODE   10903 New Hampshire Building 66, Room 1512   Silver Spring MD 20993   301/796-6402   Email: peter.allen@fda.hhs.gov