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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K261458
Device Name ATTUNE Total Knee System; ATTUNE Cementless Knee System
Applicant
DePuy Ireland UC
Loughbeg,Ringaskiddy
Cork,  IE
Applicant Contact Paige Myers
Correspondent
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Paige Myers
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received05/01/2026
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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