| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER |
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| Generic Name | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
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| Regulation Number | 888.3310 |
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| Applicant | Depuy, A Johnson & Johnson Co.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581 |
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| PMA Number | P960054 |
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| Supplement Number | S002 |
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| Date Received | 07/30/1999 |
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| Decision Date | 12/07/1999 |
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| Reclassified Date | 05/30/2002 |
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| Product Code |
KWZ |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for a design modification made to the S-ROM constrained liner so to be used withthe DePuy Duraloc and Solution Acetabular Cup Systems. This device is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. |
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