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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.
 
Trade NameBIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Nametotal hip resurfacing prosthesis, metal-on-metal
ApplicantSMITH&NEPHEW ORTHOPAEDICS
PMA NumberP040033
Date Received07/19/2004
Decision Date05/09/2006
Product Code
NXT[ Registered Establishments with NXT ]
Docket Number 06M-0193
Notice Date 05/09/2006
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the birmingham hip resurfacing (bhr) system. The bhr system is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The hgr system is intended for use in patients requiring primary hip resurfacing arthroplasty due to: 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 bhr 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: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S023 
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