PMA P830055S380

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S380
Product code: NJL
Decision date: 2026-10-05
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: removal of a duplicate inspection performed at the DePuy Cork facility for the Attune CR Femoral Components of the LCS® Total Knee System

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S380
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-10-05
Decision code: OK30
Date received: 2026-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of a duplicate inspection performed at the DePuy Cork facility for the Attune CR Femoral Components of the LCS® Total Knee System