FDA.reportPublic FDA data

PMA P830055S247

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S247
Product code
NJL
Decision date
2020-06-16
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Addition of an alternate casting site for the ATTUNE Revision Femoral Component material casting process. This change will add the DePuy Synthes Raynham, MA facility in addition to Orchid Orthopedic Solutions, the current external supplier.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S247
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-06-16
Decision code
OK30
Date received
2020-05-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate casting site for the ATTUNE Revision Femoral Component material casting process. This change will add the DePuy Synthes Raynham, MA facility in addition to Orchid Orthopedic Solutions, the current external supplier.