PMA P830055S369

Device
LCS® Total Knee System- ATTUNE™ Revision Rotating Platform Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S369
Product code
NJL
Decision date
2026-08-21
Classification
Orthopedic
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
addition of a sterilization site, Shanghai JPY IonTech. Co. Ltd, for the Tibial Trays of the ATTUNE Revision Rotating Platform (RP) Knee System

Current openFDA PMA Record#

Device
LCS® Total Knee System- ATTUNE™ Revision Rotating Platform Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S369
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2026-08-21
Decision code
OK30
Date received
2026-07-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
addition of a sterilization site, Shanghai JPY IonTech. Co. Ltd, for the Tibial Trays of the ATTUNE Revision Rotating Platform (RP) Knee System