PMA P830055S349

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S349
Product code: NJL
Decision date: 2025-09-09
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: a machining process change for manufacturing metal femoral components of the LCS Total Knee System at the DePuy Suzhou facility, Suzhou, China

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S349
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-09-09
Decision code: OK30
Date received: 2025-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a machining process change for manufacturing metal femoral components of the LCS Total Knee System at the DePuy Suzhou facility, Suzhou, China