PMA P830055S354

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S354
Product code: NJL
Decision date: 2025-12-11
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: additional Final Clean line during the manufacturing of femoral components of the LCS Total Knee System at the DePuy Ireland, Cork Manufacturing site

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S354
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-12-11
Decision code: OK30
Date received: 2025-12-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: additional Final Clean line during the manufacturing of femoral components of the LCS Total Knee System at the DePuy Ireland, Cork Manufacturing site