PMA P830055S235

Device
LCS(R) Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S235
Product code
NJL
Decision date
2019-11-21
Classification
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for the use of components of the ATTUNE Revision Knee System with compatible components of the ATTUNE Primary Cemented and Cementless devices.

Current openFDA PMA Record#

Device
LCS(R) Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S235
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2019-11-21
Decision code
APPR
Date received
2019-08-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the use of components of the ATTUNE Revision Knee System with compatible components of the ATTUNE Primary Cemented and Cementless devices.