PMA P830055S358

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S358
Product code: NJL
Decision date: 2026-02-13
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: sterilization dose range expansion, increase in thickness of in-process SZ41 component, elimination of trimming after compression molding and change to the contact material used to mold the top surface of the in-process component of the ATTUNE Porous Medialized Dome and Anatomic Patella of the LCS Total Knee System

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S358
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-02-13
Decision code: OK30
Date received: 2026-01-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: sterilization dose range expansion, increase in thickness of in-process SZ41 component, elimination of trimming after compression molding and change to the contact material used to mold the top surface of the in-process component of the ATTUNE Porous Medialized Dome and Anatomic Patella of the LCS Total Knee System