PMA P830055S359

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S359
Product code: NJL
Decision date: 2026-01-30
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: additional DePuy Ireland, Cork facility for casting of the Attune Rotating Platform (RP) Revision Tibial Tray components of the LCS Total Knee System

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S359
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-01-30
Decision code: OK30
Date received: 2026-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: additional DePuy Ireland, Cork facility for casting of the Attune Rotating Platform (RP) Revision Tibial Tray components of the LCS Total Knee System