PMA P830055S282

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S282
Product code: NJL
Decision date: 2022-03-08
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Equipment changes for the LCS Total Knee System from current Neiodymium Yttrium Aluminum Garnet (YAG) Laser equipment to Ultraviolet (UV) Laser equipment for direct marking of UHMWPE components at an approved supplier.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S282
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-03-08
Decision code: OK30
Date received: 2022-02-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Equipment changes for the LCS Total Knee System from current Neiodymium Yttrium Aluminum Garnet (YAG) Laser equipment to Ultraviolet (UV) Laser equipment for direct marking of UHMWPE components at an approved supplier.