PMA P830055S259

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S259
Product code: NJL
Decision date: 2020-11-27
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Establish the SAFC St. Louis site as an additional supplier of AOX antioxidant solution to ensure continued availability of the AOX bar stock material, which is used in manufacture of the ATTUNE Revision CRS Rotating Platform Inserts, the ATTUNE CR Rotating Platform Inserts, the ATTUNE PS Rotating Platform Inserts, theSigma Rotating Platform AO Curved Tibial Inserts, and the Sigma Rotating Platform AO Stabilized Tibial Inserts at the DePuy Cork site; and of the LCS Complete RPS AOX Inserts, the LCS Complete RP AOX Inserts and the Sigma RPF AOX Inserts at the DePuy Raynham site.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S259
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2020-11-27
Decision code: OK30
Date received: 2020-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Establish the SAFC St. Louis site as an additional supplier of AOX antioxidant solution to ensure continued availability of the AOX bar stock material, which is used in manufacture of the ATTUNE Revision CRS Rotating Platform Inserts, the ATTUNE CR Rotating Platform Inserts, the ATTUNE PS Rotating Platform Inserts, theSigma Rotating Platform AO Curved Tibial Inserts, and the Sigma Rotating Platform AO Stabilized Tibial Inserts at the DePuy Cork site; and of the LCS Complete RPS AOX Inserts, the LCS Complete RP AOX Inserts and the Sigma RPF AOX Inserts at the DePuy Raynham site.