PMA P830055S281

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S281
Product code: NJL
Decision date: 2022-02-18
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Addition of a new Final Cleanline for Poly Product and the movement of process steps from one building to a second building under the same establishment and address for several Knee components.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S281
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-02-18
Decision code: OK30
Date received: 2022-02-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new Final Cleanline for Poly Product and the movement of process steps from one building to a second building under the same establishment and address for several Knee components.