PMA P830055S353

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S353
Product code: NJL
Decision date: 2025-12-09
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: changes to the in-process monitoring of the packaging for LCS® Total Knee System and Ceramax Ceramic Hip System components at the DePuy Suzhou, China facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S353
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-12-09
Decision code: OK30
Date received: 2025-12-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the in-process monitoring of the packaging for LCS® Total Knee System and Ceramax Ceramic Hip System components at the DePuy Suzhou, China facility