FDA.reportPublic FDA data

PMA P830055S255

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S255
Product code
NJL
Decision date
2020-09-08
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Two changes to the current cleaning agents utilized in final and in-process cleaning: 1) The existing detergent (Galvex 17.30) is replaced by an alternate cleaning detergent (Liquinox); and 2) A new biocide (Acticide SPX) replaced the existing biocide (Dowicil 75) in Citrisurff formulation. These new cleaning agents are used in in-process cleaning and final cleaning steps during the manufacturing process.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S255
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-09-08
Decision code
OK30
Date received
2020-08-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Two changes to the current cleaning agents utilized in final and in-process cleaning: 1) The existing detergent (Galvex 17.30) is replaced by an alternate cleaning detergent (Liquinox); and 2) A new biocide (Acticide SPX) replaced the existing biocide (Dowicil 75) in Citrisurff formulation. These new cleaning agents are used in in-process cleaning and final cleaning steps during the manufacturing process.