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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 K253197
Device Name ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE P43 ED82
Applicant Contact Sierra Robinson
Correspondent
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE P43 ED82
Correspondent Contact Hannah Foley
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received09/26/2025
Decision Date 11/19/2025
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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