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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.
 
DeviceCONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantMicroPort Orthopedics Inc.
5677 AIRLINE RD
ARLINGTON, TN 38002
PMA NumberP030042
Date Received09/30/2003
Decision Date11/03/2009
Withdrawal Date 07/17/2014
Product Code NXT 
Docket Number 09M-0540
Notice Date 11/18/2009
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION UTILIZING CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR USE IN RESURFACING HIPARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATUREPATIENTS HAVING THE FOLLOWING CONDITIONS:1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS,TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/ DEVELOPMENTAL DISLOCATION OF THEHIP (DDH), OR2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIRRELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIPARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE IPSILATERAL HIP JOINT REVISION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S003 S004 
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