PMA P830055

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S303
Product code: NJL
Decision date: 2026-08-27
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: for addition of Final Clean Line #5 (FCL#5) and Final Clean Line #6 (FCL#6) as additional final cleaning assets for metal products manufactured at the DePuy Suzhou facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S373
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-08-27
Decision code: OK30
Date received: 2026-08-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for addition of Final Clean Line #5 (FCL#5) and Final Clean Line #6 (FCL#6) as additional final cleaning assets for metal products manufactured at the DePuy Suzhou facility