PMA P830055S299

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S299
Product code: NJL
Decision date: 2022-10-07
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Change to inspection frequency of Attune CR and PS products during the HAAS grinding process at the Johnson & Johnson Medical (DePuy Suzhou) Ltd manufacturing site.

Current openFDA PMA Record#

Device: LCS® Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S299
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-10-07
Decision code: OK30
Date received: 2022-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to inspection frequency of Attune CR and PS products during the HAAS grinding process at the Johnson & Johnson Medical (DePuy Suzhou) Ltd manufacturing site.