PMA P830055S362

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S362
Product code: NJL
Decision date: 2026-04-10
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: changes to the end-stage passivation process for components of the LCS Total Knee System and Ceramax Ceramic Hip System at the DePuy Cork, Leeds and Suzhou sites

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S362
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-04-10
Decision code: OK30
Date received: 2026-03-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the end-stage passivation process for components of the LCS Total Knee System and Ceramax Ceramic Hip System at the DePuy Cork, Leeds and Suzhou sites