PMA P060037S093

Device: NexGen© LPSFlex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S093
Product code: NJL
Decision date: 2025-04-09
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: a change to biological cycle time upgrade at the Zimmer Orthopedics Manufacturing Limited location at Shannon, Ireland facility

Current openFDA PMA Record#

Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S093
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-04-09
Decision code: OK30
Date received: 2025-03-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to biological cycle time upgrade at the Zimmer Orthopedics Manufacturing Limited location at Shannon, Ireland facility