PMA P060037S067

Device: NexGen LPS-Flex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S067
Product code: NJL
Decision date: 2020-09-24
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Replacement of the Prolong UHMWPE crosslinked material specification document, change in references of inspection methodology procedure from the firms internal document to ASTM standards, removal of Free Radical Level by Electron Spin Resonance requirement, and elimination of critical process parameters from the specification document as the ownership of the process is being transferred to a supplier and the supplier will be responsible to maintain these critical process parameters and process monitoring.

Current openFDA PMA Record#

Device: NexGen LPS-Flex/LPS Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S067
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2020-09-24
Decision code: OK30
Date received: 2020-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the Prolong UHMWPE crosslinked material specification document, change in references of inspection methodology procedure from the firms internal document to ASTM standards, removal of Free Radical Level by Electron Spin Resonance requirement, and elimination of critical process parameters from the specification document as the ownership of the process is being transferred to a supplier and the supplier will be responsible to maintain these critical process parameters and process monitoring.