PMA P830055S295

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S295
Product code: NJL
Decision date: 2022-09-01
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Automation of an in-process cleaning process for the removal of buffing compounds from products under the LCS® Total Knee System.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S295
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-09-01
Decision code: OK30
Date received: 2022-08-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Automation of an in-process cleaning process for the removal of buffing compounds from products under the LCS® Total Knee System.