PMA P060037S077

Device: NexGen® LPS-Flex / LPS-Mobile Bearing Knee
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S077
Product code: NJL
Decision date: 2022-02-10
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Relocation of some manufacturing steps and in-process cleaning steps for Fluted Mobile Stemable Tray Set Screw, which is a sub-component of NexGen LPS Mobile Knee Fluted Stem Mobile Knee Precoat Tibial Baseplate.

Current openFDA PMA Record#

Device: NexGen® LPS-Flex / LPS-Mobile Bearing Knee
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S077
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-02-10
Decision code: OK30
Date received: 2022-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of some manufacturing steps and in-process cleaning steps for Fluted Mobile Stemable Tray Set Screw, which is a sub-component of NexGen LPS Mobile Knee Fluted Stem Mobile Knee Precoat Tibial Baseplate.