PMA P830055

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S303
Product code: NJL
Decision date: 2026-06-03
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: an increase in the maximum allowable number of baskets of product that can be processed in the cleaning and passivation tanks for Final Metal Clean Lines

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S366
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-06-03
Decision code: OK30
Date received: 2026-05-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an increase in the maximum allowable number of baskets of product that can be processed in the cleaning and passivation tanks for Final Metal Clean Lines