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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceREFLECTION CERAMIC ACETABULAR SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP030022
Supplement NumberS008
Date Received10/02/2007
Decision Date02/18/2009
Withdrawal Date08/31/2022
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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