PMA P830055S355

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S355
Product code: NJL
Decision date: 2025-12-15
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: removal of a duplicate sample (roving) inspection during the manufacturing process of LCS® Total Knee System patella components at Johnson & Johnson Medical (DePuy Suzhou) Ltd., Suzhou Jiangsu, China facility

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S355
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-12-15
Decision code: OK30
Date received: 2025-12-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of a duplicate sample (roving) inspection during the manufacturing process of LCS® Total Knee System patella components at Johnson & Johnson Medical (DePuy Suzhou) Ltd., Suzhou Jiangsu, China facility