PMA P060037S096

Device: NexGen® LPS-Flex / LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S096
Product code: NJL
Decision date: 2026-01-16
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: approval for the introduction of an additional inspection step in the manufacturing process of the NexGen® LPS-Flex / LPS Mobile Bearing Knee System to enhance the identification of components

Current openFDA PMA Record#

Device: NexGen® LPS-Flex / LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S096
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-01-16
Decision code: APPR
Date received: 2025-12-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the introduction of an additional inspection step in the manufacturing process of the NexGen® LPS-Flex / LPS Mobile Bearing Knee System to enhance the identification of components