PMA P830055S297

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S297
Product code: NJL
Decision date: 2022-10-04
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Change in inspection frequency that will reduce size inspection of casting trays from 100% of all parts to one part per batch for ATTUNE FB and RP castings.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S297
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-10-04
Decision code: OK30
Date received: 2022-09-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in inspection frequency that will reduce size inspection of casting trays from 100% of all parts to one part per batch for ATTUNE FB and RP castings.