PMA P830055S381

Device: ATTUNE Rotating Platform (RP) Total Knee System, and ATTUNE Revision Rotating Platform (RP) Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S381
Product code: NJL
Decision date: 2026-10-27
Classification: Orthopedic
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: addition of a new Coherent Laser Automatic Processing System at DePuy Synthes manufacturing facility in Raynham, Massachusetts

Current openFDA PMA Record#

Device: ATTUNE Rotating Platform (RP) Total Knee System, and ATTUNE Revision Rotating Platform (RP) Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S381
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2026-10-27
Decision code: OK30
Date received: 2026-10-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new Coherent Laser Automatic Processing System at DePuy Synthes manufacturing facility in Raynham, Massachusetts