PMA P830055S341

Device: LCS(R) TOTAL KNEE SYSTEM
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S341
Product code: NJL
Decision date: 2025-07-18
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: approval for the changes to the clean room environment and packaging rooms for TruMatch instruments of the LCS Total Knee System.

Current openFDA PMA Record#

Device: LCS(R) TOTAL KNEE SYSTEM
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S341
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-07-18
Decision code: APPR
Date received: 2025-03-19
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the changes to the clean room environment and packaging rooms for TruMatch instruments of the LCS Total Knee System.