| 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 | STELKAST SURPASS ACETABULAR SYSTEM |
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| Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Applicant | STELKAST COMPANY
200 HIDDEN VALLEY ROAD
MCMURRAY, PA 15317 |
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| PMA Number | P040051 |
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| Date Received | 12/27/2004 |
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| Decision Date | 05/12/2006 |
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Withdrawal Date
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05/12/2016 |
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| Product Code |
MRA |
| Docket Number | 07M-0109 |
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| Notice Date | 03/26/2007 |
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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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Approval Order Statement
APPROVAL FOR THE STELKAST SURPASS ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR CEMENTLESS USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE INDIVIDUALS 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: |
S001 S002 |
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