FDA.reportPublic FDA data

PMA P830055S269

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S269
Product code
NJL
Decision date
2021-06-30
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for the introduction of two additional inspections at the machining process step for the screw thread feature of the Attune Revision Stems of the LCS Total Knee System.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S269
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2021-06-30
Decision code
APPR
Date received
2021-06-16
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the introduction of two additional inspections at the machining process step for the screw thread feature of the Attune Revision Stems of the LCS Total Knee System.