PMA P830055S348

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S348
Product code: NJL
Decision date: 2025-08-29
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: reducing receiving inspection (RI) for finished goods components at DePuy Ireland UC, Cork facility in Ireland, for the Attune Inserts under the LCS Total Knee System product family

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S348
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2025-08-29
Decision code: OK30
Date received: 2025-08-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reducing receiving inspection (RI) for finished goods components at DePuy Ireland UC, Cork facility in Ireland, for the Attune Inserts under the LCS Total Knee System product family