PMA P830055S294

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S294
Product code: NJL
Decision date: 2022-08-15
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Manufacturing change to the inspection frequency from 100% to AQL 1.0 for CTQ inspection dimensions #2, #3, #4, #5, and #7 for the Attune Revision CRS RP insert reinforcing pins, which are components of the LCS® Total Knee System.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S294
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-08-15
Decision code: OK30
Date received: 2022-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change to the inspection frequency from 100% to AQL 1.0 for CTQ inspection dimensions #2, #3, #4, #5, and #7 for the Attune Revision CRS RP insert reinforcing pins, which are components of the LCS® Total Knee System.