PMA P060037

Device: NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S082
Product code: NJL
Decision date: 2026-09-24
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: introduction of Elma 3-Stage Parts Washer for the femoral components of the NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System at the Zimmer Inc. facility in Warsaw, Indiana

Current openFDA PMA Record#

Device: NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S099
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-09-24
Decision code: OK30
Date received: 2026-09-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of Elma 3-Stage Parts Washer for the femoral components of the NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System at the Zimmer Inc. facility in Warsaw, Indiana