PMA P830055S277

Device: LCS Total Knee System
Applicant: Depuy, Inc.
Product code: NJL
Decision date: 2022-07-06
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for a manufacturing site located at Wilsey Tool Company, 140 Penn Am Drive, Quakertown, PA 18951 to conduct the contract manufacturing for the cutting block instruments used as part of the LCS® Total Knee System.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S277
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-07-06
Decision code: APPR
Date received: 2021-11-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Wilsey Tool Company, 140 Penn Am Drive, Quakertown, PA 18951 to conduct the contract manufacturing for the cutting block instruments used as part of the LCS® Total Knee System.