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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 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.
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Smith & Nephew, Inc.
7135 goodlett farms parkway
cordova, TN 38016
PMA NumberP030022
Supplement NumberS008
Date Received10/02/2007
Decision Date02/18/2009
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typenormal 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.