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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOSTEONICS CONSTRAINED ACETABULAR INSERT
Generic NameProsthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Number888.3310
ApplicantHOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677
PMA NumberP960047
Date Received12/16/1996
Decision Date06/13/1997
Reclassified Date 04/30/2002
Product Code KWZ 
Docket Number 97M-0459
Notice Date 11/17/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE OSTEONICS CONSTRAINED ACETABULAR INSERT. THIS DEVICE IS INDICATED FOR USE AS A COMPONENT OF A TOTAL HIP PROSTHESIS IN PATIENTS AT HIGH RISK OF HIP DISLOCATION DUE TO A HISTORY OF PRIOR DISLOCATION, BONE LOSS, JOINT LAXITY, OR INTRAOPERATIVE INSTABILITY.
Supplements:  S002 S003 S001 
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