PMA P830055S300

Device: LCS® Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S300
Product code: NJL
Decision date: 2022-11-14
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Automation and electronic storage of the furnace cycles at the Load Furnace process step for Knee components of the LCS® Total Knee System.

Current openFDA PMA Record#

Device: LCS® Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S300
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-11-14
Decision code: OK30
Date received: 2022-10-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Automation and electronic storage of the furnace cycles at the Load Furnace process step for Knee components of the LCS® Total Knee System.