PMA P830055S278

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S278
Product code: NJL
Decision date: 2022-01-19
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Removal of the post irradiation heat treatment process step for the Attune Revision Cruciate Retaining System (CRS) Rotating Platform (RP) Tibial Inserts that are manufactured in Cork, Ireland.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S278
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-01-19
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Removal of the post irradiation heat treatment process step for the Attune Revision Cruciate Retaining System (CRS) Rotating Platform (RP) Tibial Inserts that are manufactured in Cork, Ireland.