PMA P830055S356

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S356
Product code: NJL
Decision date: 2026-01-16
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for the addition of an inspection at the Bench process step in the Foundry Value Stream which will measure the AP Spread Dimension of the Attune CR Femoral parts of the LCS Total Knee System.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S356
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-01-16
Decision code: APPR
Date received: 2025-12-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of an inspection at the Bench process step in the Foundry Value Stream which will measure the AP Spread Dimension of the Attune CR Femoral parts of the LCS Total Knee System.