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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.
 
DeviceREFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP030022
Supplement NumberS016
Date Received07/07/2010
Decision Date07/30/2010
Withdrawal Date 08/31/2022
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE TO SMITH & NEPHEW SPECIFICATION M000286 IN TERMS OF THE AVERAGE VOLUME POROSITY OF THE POROUS COATING COMPLYING WITH THE AVERAGE VOLUME POROSITY OF 30% - 70%.
Post-Approval StudyShow Report Schedule and Study Progress
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