| 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. |
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| Device | TRILOGY AB ACETABULAR SYSTEM |
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| Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Applicant | ZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708 |
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| PMA Number | P040048 |
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| Date Received | 12/14/2004 |
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| Decision Date | 06/28/2006 |
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Withdrawal Date
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08/29/2012 |
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| Product Code |
MRA |
| Docket Number | 07M-0259 |
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| Notice Date | 06/28/2007 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE TRILOGY AB ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR EITHER CEMENTED OR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY SURGERY FOR REHABILITATING HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S008 S009 S010 S011 S012 S014
S015 S016 S017 |
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