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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 NameS-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
Classification Nameprosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantDEPUY, A JOHNSON & JOHNSON CO.
PMA NumberP960054
Supplement NumberS002
Date Received07/30/1999
Decision Date12/07/1999
Product Code
KWZ[ Registered Establishments with KWZ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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