| 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 | C2 A-TAPER ACETABULAR SYSTEM |
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| Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Applicant | Biomet, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
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| PMA Number | P050009 |
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| Date Received | 03/14/2005 |
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| Decision Date | 12/16/2005 |
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Withdrawal Date
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07/23/2015 |
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| Product Code |
MRA |
| Docket Number | 06M-0015 |
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| Notice Date | 01/13/2006 |
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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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Approval Order Statement
APPROVAL FOR THE C2A-TAPER ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND POST-TRAUMATIC ARTHRITIS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S004 S005 S007 S009 |
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