FDA.reportPublic FDA data

PMA P830055S262

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S262
Product code
NJL
Decision date
2021-02-19
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Rework process for the removal of micro scratches which occurs during the manufacture of components of the LCS® Total Knee System that aremanufactured at the DePuy Raynham, MA manufacturing facility.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S262
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2021-02-19
Decision code
OK30
Date received
2021-02-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Rework process for the removal of micro scratches which occurs during the manufacture of components of the LCS® Total Knee System that aremanufactured at the DePuy Raynham, MA manufacturing facility.