PMA P830055S285

Device: LCS(R) Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S285
Product code: NJL
Decision date: 2022-03-29
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Move GSR testing from a sub-tier supplier (Cambridge Polymer Group) of Mitsubishi Chemicals Advanced Materials (also known as MediTECH Medical Polymers) to Depuy Orthopaedics (i.e., in-house testing) for UHMWPE components used in the LCS® Total Knee System.

Current openFDA PMA Record#

Device: LCS(R) Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S285
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-03-29
Decision code: OK30
Date received: 2022-03-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move GSR testing from a sub-tier supplier (Cambridge Polymer Group) of Mitsubishi Chemicals Advanced Materials (also known as MediTECH Medical Polymers) to Depuy Orthopaedics (i.e., in-house testing) for UHMWPE components used in the LCS® Total Knee System.