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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCeramax Ceramic Total Hip System
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw, IN 46582
PMA NumberP070026
Supplement NumberS048
Date Received06/23/2017
Decision Date07/13/2017
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Two changes to the SUMMIT and TRI-LOCK BPS hip stems: automation of the turn taper and laser etch operations, and an increase in degrease process capacity from 2 units/cycle to 5 units/cycle. A third change is proposed to the TRI-LOCK BPS hip stems, which will be to implement a new protective guard to be used during the polishing process.
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