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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

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: 1997. 
Address of Standards Development 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
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
§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
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