PMA P060037S082

Device: NexGen® LPS-Flex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S082
Product code: NJL
Decision date: 2022-10-06
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Change in fluorescent penetrant inspection (FPI) materials used during an in-process quality control validation on NexGen LPS/LPS-Flex femoral components and tibia baseplate components.

Current openFDA PMA Record#

Device: NexGen® LPS-Flex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S082
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-10-06
Decision code: OK30
Date received: 2022-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in fluorescent penetrant inspection (FPI) materials used during an in-process quality control validation on NexGen LPS/LPS-Flex femoral components and tibia baseplate components.