|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||ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM|
|Classification Name||prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the approved surgical technique to add an optional technique for making the femoral bone cuts for the lps-flex mobile femoral component. The device, as modified, will be marketed under the trade name zimmer nexgen lps-flex mobile and lps-mobile bearing knee systems and is indicated for patients with severe knee pain and disability due to osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, and moderate valgus, varus, or flexion deformities (i. E. , valgus/varus deformity of <=15 degrees, fixed flexion deformity of <=10 degrees).