PMA P830055S350

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S350
Product code: NJL
Decision date: 2025-09-26
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: process change to the manual box buffing step for Attune Cemented CRS Femoral Components of the LCS Total Knee System manufactured at the DePuy Raynham, MA facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S350
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-09-26
Decision code: OK30
Date received: 2025-09-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: process change to the manual box buffing step for Attune Cemented CRS Femoral Components of the LCS Total Knee System manufactured at the DePuy Raynham, MA facility