PMA P830055S293

Device: LCS(R) Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S293
Product code: NJL
Decision date: 2022-08-11
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval to change the verification of castings for implants during the manufacturing process for the LCS® Total Knee System, by including the tail code reconciliation as an additional verification step for manufacturing process.

Current openFDA PMA Record#

Device: LCS(R) Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S293
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-08-11
Decision code: APPR
Date received: 2022-07-15
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to change the verification of castings for implants during the manufacturing process for the LCS® Total Knee System, by including the tail code reconciliation as an additional verification step for manufacturing process.