FDA.reportPublic FDA data

PMA P830055S253

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S253
Product code
NJL
Decision date
2020-07-17
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Equipment used to inspect Attune PS Cemented Femoral Components at the inspection process step following the Plastic Drag process step from the current calibrated gages to the automated Redlux Coordinate measurement machine (CMMQ0088) at the DePuy Cork Manufacturing Facility.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S253
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-07-17
Decision code
OK30
Date received
2020-07-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Equipment used to inspect Attune PS Cemented Femoral Components at the inspection process step following the Plastic Drag process step from the current calibrated gages to the automated Redlux Coordinate measurement machine (CMMQ0088) at the DePuy Cork Manufacturing Facility.