PMA P830055S296

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S296
Product code: NJL
Decision date: 2022-10-04
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Change to the pressure & temperature parameter settings to accommodate the use of six (6) cavities that are used to the packaging process step for some components of the LCS Total Knee systems.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S296
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-10-04
Decision code: OK30
Date received: 2022-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the pressure & temperature parameter settings to accommodate the use of six (6) cavities that are used to the packaging process step for some components of the LCS Total Knee systems.