| 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 | NOVATION CERAMIC ARTICULATION HIP SYSTEM |
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| Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Applicant | EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 |
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| PMA Number | P050039 |
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| Date Received | 10/27/2005 |
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| Decision Date | 07/05/2007 |
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|
Withdrawal Date
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12/31/2020 |
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| Product Code |
MRA |
| Docket Number | 07M-0287 |
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| Notice Date | 07/20/2007 |
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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 NOVATION CERAMIC ARTICULATION HIP SYSTEM. THIS DEVICE IS INDICATED FOR PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE 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: |
S016 S008 S009 S014 S017 S015 S011 S012 S013 S018 S002
S003 S004 S001 S020 S021 S019 S005 S007 S010 |
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