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. |
|
Device | LCS TOTAL KNEE SYSTEM |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P830055 |
Supplement Number | S126 |
Date Received | 01/31/2012 |
Decision Date | 03/30/2012 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD THE DEPUY UNIVERSAL STEM EXTENSIONS AS COMPATIBLE COMPONENTS TO THE PREVIOUSLY APPROVED LCS COMPLETE MODULAR FEMORAL COMPONENTS, LCS COMPLETE REVISION FEMORAL COMPONENTS, AND MBT TIBIAL TRAYS, AND TO ADD THE DEPUY UNIVERSAL FEMORAL METAPHYSEAL SLEEVES AS COMPATIBLE COMPONENTS TO THE LCS COMPLETE REVISION FEMORAL COMPONENTS. |
|
|