PMA P060037S095

Device: NexGen© LPSFlex/ LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S095
Product code: NJL
Decision date: 2025-08-18
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: use of the new ZOML Shannon Analytical Test Services (ATS) Laboratory for conducting routine cleanliness testing of NexGen LPS-Flex Mobile Bearing Knee System components at the ZOML Shannon, Ireland facility

Current openFDA PMA Record#

Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S095
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-08-18
Decision code: OK30
Date received: 2025-08-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: use of the new ZOML Shannon Analytical Test Services (ATS) Laboratory for conducting routine cleanliness testing of NexGen LPS-Flex Mobile Bearing Knee System components at the ZOML Shannon, Ireland facility