|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.|
|Trade Name||OXFORD MENISCAL UNICOMPARTMENTAL KNEE|
|Classification Name||prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing|
|Generic Name||knee, unicompartmental, metal/polymer, cemented, mobile bearing|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the process specifications for the 9-stage kerry cleaning plant used in the ultrasonic cleaning of the oxford meniscal unicompartmental knee system metallic components (femoral and tibial). The changes require detailed monitoring of the ultrasonic equipment to ensure the adequacy of its output.