PMA P830055S357

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S357
Product code: NJL
Decision date: 2026-02-12
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for the addition of an optional touch-up CMM inspection at the Post Plastic Drag process step for the ATTUNE Primary Femoral CR and PS parts of the LCS® Total Knee System.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S357
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-02-12
Decision code: APPR
Date received: 2026-01-13
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of an optional touch-up CMM inspection at the Post Plastic Drag process step for the ATTUNE Primary Femoral CR and PS parts of the LCS® Total Knee System.