PMA P060037

Device: NexGen® LPS-Flex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S082
Product code: NJL
Decision date: 2026-10-16
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: expansion of ISO Class 7 packaging cleanroom space and corridor at the Zimmer Inc Warsaw West facility

Current openFDA PMA Record#

Device: NexGen® LPS-Flex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S100
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-10-16
Decision code: OK30
Date received: 2026-10-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: expansion of ISO Class 7 packaging cleanroom space and corridor at the Zimmer Inc Warsaw West facility