PMA P830055S338

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S338
Product code: NJL
Decision date: 2025-02-21
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: to introduce an alternate manufacturing consumable (i.e., water-based binder), and associated equipment assets (spray booths, binder rooms) into the metal-porous coating processes

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S338
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-02-21
Decision code: OK30
Date received: 2025-01-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to introduce an alternate manufacturing consumable (i.e., water-based binder), and associated equipment assets (spray booths, binder rooms) into the metal-porous coating processes