PMA P830055S347

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S347
Product code: NJL
Decision date: 2025-08-05
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: the removal of shear bar verification testing (post coating sintering process) for the products which involve Titanium and Cobalt Chromium Molybdenum coating within the CERAMAX CERAMIC HIP SYSTEM and LCS Total Knee System

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S347
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-08-05
Decision code: OK30
Date received: 2025-07-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the removal of shear bar verification testing (post coating sintering process) for the products which involve Titanium and Cobalt Chromium Molybdenum coating within the CERAMAX CERAMIC HIP SYSTEM and LCS Total Knee System