PMA P830055S367

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S367
Product code: NJL
Decision date: 2026-06-29
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: introduction of an additional size verification inspection step to the Attune Cementless Posterior Stabilizing and Attune Cementless Cruciate Retaining Femoral components of the LCS® Total Knee System at the DePuy Cork, Ireland facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S367
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-06-29
Decision code: APPR
Date received: 2026-06-03
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of an additional size verification inspection step to the Attune Cementless Posterior Stabilizing and Attune Cementless Cruciate Retaining Femoral components of the LCS® Total Knee System at the DePuy Cork, Ireland facility