PMA P830055S346

Device
ATTUNE™ Revision Rotating Platform (RP) Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S346
Product code
NJL
Decision date
2025-12-18
Classification
Orthopedic
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for the ATTUNE™ Revision Rotating Platform (RP) Thick Tibial Base as part of the ATTUNE™ Revision Rotating Platform (RP) Knee System.

Current openFDA PMA Record#

Device
ATTUNE™ Revision Rotating Platform (RP) Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S346
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2025-12-18
Decision code
APPR
Date received
2025-06-24
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the ATTUNE™ Revision Rotating Platform (RP) Thick Tibial Base as part of the ATTUNE™ Revision Rotating Platform (RP) Knee System.