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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDURALOC OPTION CERAMIC-ON-CERAMIC HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip system,ceramic articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP040023
Supplement NumberS003
Date Received11/21/2005
Decision Date12/22/2005
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling that include: 1) the addition of an intraoperative precaution advising the surgeon of the necessity for correct positioning of the insert component prior to assembling it to the metal outer shell and examining the ceramic liner following final assembly, and 2) updating the adverse event table to reflect the higher rate of intraoperative chipping experienced in the first six months of u. S. Distribution.
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