Premarket Approval (PMA)

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: LPS-Flex Mobile and LPS Mobioe Bearing Knee System
• 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: S052
• Date Received: 09/29/2017
• Decision Date: 10/19/2017
• Product Code: NJL
• Advisory Committee: Orthopedic
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Change in manufacturing materials used during the manufacturing of the device.