PMA P830055S371

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S371
Product code: NJL
Decision date: 2026-08-21
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: a formulation change in the drag finishing agent during the manufacturing of some LCS® Total Knee System components at Johnson & Johnson Medical (DePuy Suzhou) facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S371
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-08-21
Decision code: OK30
Date received: 2026-08-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a formulation change in the drag finishing agent during the manufacturing of some LCS® Total Knee System components at Johnson & Johnson Medical (DePuy Suzhou) facility