PMA P830055S363

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S363
Product code: NJL
Decision date: 2026-03-27
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: addition of an alternate masking aid at the porous coating preparation process step for the Attune Knee components of the LCS Total Knee System within the Cork foundry value stream located at the DePuy Ireland UC manufacturing facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S363
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-03-27
Decision code: OK30
Date received: 2026-03-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of an alternate masking aid at the porous coating preparation process step for the Attune Knee components of the LCS Total Knee System within the Cork foundry value stream located at the DePuy Ireland UC manufacturing facility