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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.
 
DeviceCORMET HIP RESURFACING SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantCORIN U.S.A.
12750 Citrus Park Lane
Suite 120
Tampa, FL 33607
PMA NumberP050016
Date Received03/30/2005
Decision Date07/03/2007
Product Code NXT 
Docket Number 07M-0286
Notice Date 07/20/2007
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CORMET HIP RESURFACING SYSTEM. THE CORMET HIP RESURFACING SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT. THE DEVICE IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON-INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS. THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING IPSILATERAL HIP JOINT REVISION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S008  S007 S010 S001 S002 S011 S009 S005 S006 S004 S003 
S012 
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