PMA P830055S370

Device: LCS(R) TOTAL KNEE SYSTEM
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S370
Product code: NJL
Decision date: 2026-08-19
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: automation of data capture during Receiving Inspection used during manufacturing of LCS® Total Knee System components at the DePuy International Ltd, Leeds, facility

Current openFDA PMA Record#

Device: LCS(R) TOTAL KNEE SYSTEM
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S370
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-08-19
Decision code: OK30
Date received: 2026-07-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: automation of data capture during Receiving Inspection used during manufacturing of LCS® Total Knee System components at the DePuy International Ltd, Leeds, facility