FDA.reportPublic FDA data

PMA P830055S303

Device
LCS® Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S303
Product code
NJL
Decision date
2023-02-01
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Change from etching Cobalt Chrome products with Red yttrium aluminum garnet (YAG) Laser using ink to Green Beam Laser without ink at the DePuy Orthopaedics, Inc., Warsaw, IN manufacturing site.

Current openFDA PMA Record#

Device
LCS® Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S303
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2023-02-01
Decision code
OK30
Date received
2023-01-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change from etching Cobalt Chrome products with Red yttrium aluminum garnet (YAG) Laser using ink to Green Beam Laser without ink at the DePuy Orthopaedics, Inc., Warsaw, IN manufacturing site.