PMA P830055S267

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S267
Product code: NJL
Decision date: 2021-06-14
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Removing the use of bovine derivative polish and grease consumable from the manufacturing process (Matchless HF1 and Matchless 16) and replace with non-bovine polish and grease consumable (Abracut C and BG-58) in the manufacture of all LCS Complete MB Patella in DePuy Synthes, Ireland.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S267
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2021-06-14
Decision code: OK30
Date received: 2021-06-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Removing the use of bovine derivative polish and grease consumable from the manufacturing process (Matchless HF1 and Matchless 16) and replace with non-bovine polish and grease consumable (Abracut C and BG-58) in the manufacture of all LCS Complete MB Patella in DePuy Synthes, Ireland.