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 | REFLECTION CERAMIC ACETABULAR SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P030022 |
Supplement Number | S008 |
Date Received | 10/02/2007 |
Decision Date | 02/18/2009 |
Withdrawal Date
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08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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 THEMANUFACTURING 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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