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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
PMA NumberP030042
Date Received09/30/2003
Decision Date11/03/2009
Withdrawal Date 07/17/2014
Product Code
NXT[ Registered Establishments with NXT ]
Docket Number 09M-0540
Notice Date 11/18/2009
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the conserve 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. The conserve plus total resurfacing hip system 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 arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/ developmental dislocation of the hip (ddh), or 2) inflammatory arthritis such as rheumatoid arthritis. The conserve plus total resurfacing hip 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 future ipsilateral hip joint revision.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004