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Device | DURALOC OPTION CERAMIC HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P040023 |
Date Received | 05/04/2004 |
Decision Date | 05/03/2005 |
Withdrawal Date
|
04/03/2014 |
Product Code |
MRA |
Docket Number | 06M-0512 |
Notice Date | 12/20/2006 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DURALOC OPTION CERAMIC HIP SYSTEM. THE DEVICE IS INDICATED FOR NON-CEMENTED USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND POST-TRAUMATIC ARTHRITIS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S018 S019 S020 S021 S022 S024 S025 |