| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | REFLECTION CERAMIC ACETABULAR SYSTEM |
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| Classification Name | prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Generic Name | total hip arthroplasty system |
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| Applicant | SMITH & NEPHEW, INC. |
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| PMA Number | P030022 |
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| Supplement Number | S008 |
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| Date Received | 10/02/2007 |
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| Decision Date | 02/18/2008 |
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| Product Code | |
| Advisory Committee |
Orthopedic |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | location change: manufacturer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for 1) the addition of the reflection 3 (r3) ceramic (biolox forte) liners (32mm id, 36mm id), which feature a factory-assembled titanium alloy outer ring; the modified acetabular shell (i. E. , r3 acetabular shells) to accept the modified ceramic liners; and the 36mm biolox forte femoral head (+0, +4. +8); 2) an additional manufacturing site at smith & nephew orthopaedics, tuttlingen, germany, for the manufacturing and assembly of the titanium ring; and 3) a sterilization site for the r3 ceramic liners with the affixed outer metal ring at bbf sterilization services, gmbh, kernen, germany. |
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