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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.
 
DeviceS-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
Generic NameProsthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantDEPUY, A JOHNSON & JOHNSON CO.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP960054
Supplement NumberS002
Date Received07/30/1999
Decision Date12/07/1999
Reclassified Date 05/30/2002
Product Code KWZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
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