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 | NEXGEN COMPLETE KNEE SOLUTION |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | ZIMMER, INC. P.O. Box 708 Warsaw, IN 46581-0708 |
PMA Number | P060037 |
Supplement Number | S005 |
Date Received | 09/29/2008 |
Decision Date | 03/26/2009 |
Product Code |
NJL |
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 CHANGES TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT,RESULTING IN THE NEXGEN MINIMALLY INVASIVE SOLUTIONS (MIS) LPS-MOBILE TIBIAL COMPONENT.CHANGES MADE TO THE NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT INCLUDE SHORTENING THETIBIAL BASEPLATE STEM AND ADDING BROAD PROXIMAL FINS, CHANGING THE OUTER PROFILE RADIUS OF THEBASEPLATE EDGE FROM A VARIABLE RADIUS TO A CONSTANT RADIUS, AND ADDING AN ADDITIONAL SIZE (4-PLUS)TO THE CURRENT RANGE OF SIZES (1 - 8). |
|
|