PMA P830055S374

Device: LCS(R) TOTAL KNEE SYSTEM, specifically ATTUNE™ Cruciate Retaining (CR), Posterior Stabilized (PS) and Revision Femoral C
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S374
Product code: NJL
Decision date: 2026-09-03
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: addition of the DePuy Ireland, Cork facility as an alternative facility for the Hot Isostatic Pressing (HIP) and Heat treatment processing of ATTUNE(TM) Cruciate Retaining (CR), Posterior Stabilized (PS) and Revision Femoral Components casted by the Raynham Foundry

Current openFDA PMA Record#

Device: LCS(R) TOTAL KNEE SYSTEM, specifically ATTUNE™ Cruciate Retaining (CR), Posterior Stabilized (PS) and Revision Femoral C
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S374
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-09-03
Decision code: OK30
Date received: 2026-08-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of the DePuy Ireland, Cork facility as an alternative facility for the Hot Isostatic Pressing (HIP) and Heat treatment processing of ATTUNE(TM) Cruciate Retaining (CR), Posterior Stabilized (PS) and Revision Femoral Components casted by the Raynham Foundry