PMA P830055S340

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S340
Product code: NJL
Decision date: 2025-03-19
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: a formulation change to the ZF113 drag finishing agent for manufacturing components of the LCS Total Knee System in the Suzhou, China facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S340
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-03-19
Decision code: OK30
Date received: 2025-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a formulation change to the ZF113 drag finishing agent for manufacturing components of the LCS Total Knee System in the Suzhou, China facility