FDA.reportPublic FDA data

PMA P830055S302

Device
LCS(R) TOTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S302
Product code
NJL
Decision date
2023-01-30
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Addition of a laser marked 2D barcode, and post-marking 2D barcode verification as additional mechanisms for part identification and traceability throughout the manufacturing process for products from the LCS® Total Knee System, as well as approval for the removal of the second operator visual inspection of the human readable text (HRT) marking.

Current openFDA PMA Record#

Device
LCS(R) TOTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S302
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2023-01-30
Decision code
OK30
Date received
2023-01-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a laser marked 2D barcode, and post-marking 2D barcode verification as additional mechanisms for part identification and traceability throughout the manufacturing process for products from the LCS® Total Knee System, as well as approval for the removal of the second operator visual inspection of the human readable text (HRT) marking.