PMA P060037S078

Device: NexGen LPS-Flex/ LPS-Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S078
Product code: NJL
Decision date: 2022-03-23
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: 1) New 2nd tier supplier for the layer lamination process; 2) alternate adhesive material used in lamination process; 3) relocation of PET/AlOx production; and 4) alternate supplier of LLDPE sealant layer material.

Current openFDA PMA Record#

Device: NexGen LPS-Flex/ LPS-Mobile Bearing Knee System
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S078
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-03-23
Decision code: OK30
Date received: 2022-03-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 1) New 2nd tier supplier for the layer lamination process; 2) alternate adhesive material used in lamination process; 3) relocation of PET/AlOx production; and 4) alternate supplier of LLDPE sealant layer material.