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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 022 Publication Date: 09/08/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 11-215: ASTM F 897-02 (Reapproved 2007), Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws. (Orthopaedics)

Date of Standard: 2007. 
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:
Applies specifically to osteosynthesis plates and screws, but may also be used to study fretting corrosion of other devices where metal components are in contact.
Processes Affected:
510(K), PMA, IDE, PDP, DESIGN CONTROLS
Type of Standard:
 Test Methods, National, Horizontal
Extent of Recognition:
Standard provides a method to compare different materials or designs. The clinical significance of the amount of damage observed is not known, and therefore, relevant controls should be included with the submission.
Related CFR Citations and Product Codes:
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 KTT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class 2 LXT
§888.3030 Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Class 2 KTW
§888.3030 Appliance, Nail/Blade/Plate Combination, Single Component Class 2 KWK
§888.3030 Condylar Plate Fixation Implant Class 2 JDP
§888.3030 Device, Fixation, Proximal Femoral, Implant Class 2 JDO
§888.3030 Plate, Fixation, Bone Class 2 HRS
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3040 Screw, Fixation, Bone Class 2 HWC
 
Relevant Guidance:
Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components, May 1, 1995
FDA Technical Contact:
  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
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