PMA P830055S344

Device: LCS® Total Knee System - MBT Thick Tray
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S344
Product code: NJL
Decision date: 2025-05-21
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: change to the raw material casting supplier for MBT Thick Trays of the LCS Total Knee System at Warsaw, Indiana facility

Current openFDA PMA Record#

Device: LCS® Total Knee System - MBT Thick Tray
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S344
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-05-21
Decision code: OK30
Date received: 2025-04-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change to the raw material casting supplier for MBT Thick Trays of the LCS Total Knee System at Warsaw, Indiana facility