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 | 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 | S090 |
Date Received | 07/18/2005 |
Decision Date | 09/26/2005 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO: CHANGE THE NAME OF THE LCS COMPLETE M1 PS FEMORAL COMPONENT TO THE LCS COMPLETE RPS FEMORAL COMPONENT, ADD NEW SIZES ALONG WITH SOME MINOR DESIGN CHANGES TO THE RPS FEMORAL COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE M1 PS TIBIAL BEARING COMPONENT TO THE LCS COMPLETE RPS TIBIAL BEARING COMPONENT, ADD NEW BEARING THICKNESSES TO THE RPS TIBIAL BEARING COMPONENTS, AND MAKE DIMENSIONAL CHANGES TO THE TIBIAL REINFORCEMENT PIN USED WITH THE RPS TIBIAL BEARINGS; CHANGE THE CAM AND SPINE MECHANISMS FOR THE LCS COMPLETE REVISION FEMORAL AND TIBIAL BEARING COMPONENTS, ADD A MEDIUM SIZE TO THE LCS COMPLETE REVISION FEMORAL AND TIBIAL BEARING COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE REVISION TIBIAL BEARING COMPONENT FROM VVC1 TO VVC, AND MODIFY THE TIBIAL REINFORCEMENT PIN USED WITH THE VVC TIBIAL BEARINGS. |
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