PMA P830055S352

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S352
Product code: NJL
Decision date: 2025-11-26
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: reduction in inspection frequency of the surface finish and removal of an independent visual inspection during the manufacturing of ATTUNE RP PS and CR insert components of the LCS Total Knee System at the DePuy Cork, Ireland facility

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S352
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-11-26
Decision code: OK30
Date received: 2025-11-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reduction in inspection frequency of the surface finish and removal of an independent visual inspection during the manufacturing of ATTUNE RP PS and CR insert components of the LCS Total Knee System at the DePuy Cork, Ireland facility