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Recognized Consensus Standards
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Recognition List Number: 030 Publication Date: 01/15/2013 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-333: ASTM F2393-12, Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications. (Materials)

Date of Standard: 2012. 
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:
Femoral Head Components of Total Hip Replacements (THR)
Processes Affected:
510(k), IDE, HDE, PMA, PDP, Design Controls
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete Standard

This specification covers the material requirements for high-purity, dense magnesia partially stabilized zirconia (i.e., Mg-PSZ) for load bearing surgical implant applications. It does not cover finished parts (e.g., femoral heads). It is intended as a qualification of the material as delivered to the parts manufacturer.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3353 Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 OQI
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 MAY
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer Class 3 KXB
§888.3410 Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class 3 OCG
 
Relevant Guidance:
Guidance Document for the Preparation of Premarket Notification For Ceramic Ball Hip Systems, January 10, 1995
FDA Technical Contact:
  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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