PMA P830055S343

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S343
Product code: NJL
Decision date: 2025-05-02
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: process change to the final manual buff touch-up to femoral components of the LCS Total Knee System manufactured at the Raynham, MA facility

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S343
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-05-02
Decision code: OK30
Date received: 2025-04-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: process change to the final manual buff touch-up to femoral components of the LCS Total Knee System manufactured at the Raynham, MA facility