FDA.reportPublic FDA data

PMA P830055S256

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S256
Product code
NJL
Decision date
2020-09-25
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Proposal to introduce a new DMG Mori NTX 1000 Generation 2 Computer Numerical Control (CNC) to .independently complete all the machining steps and adding new Coordinate Measurement Machine (CMM) to inspect the Attune RP Revision Tibial Base components.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S256
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-09-25
Decision code
OK30
Date received
2020-09-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Proposal to introduce a new DMG Mori NTX 1000 Generation 2 Computer Numerical Control (CNC) to .independently complete all the machining steps and adding new Coordinate Measurement Machine (CMM) to inspect the Attune RP Revision Tibial Base components.