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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K240678
Device Name ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Catherine O Regan
Correspondent
Depuy Ireland UC
Loughbeg Ringaskiddy
Cork,  IE
Correspondent Contact Catherine O'Regan
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received03/11/2024
Decision Date 06/18/2024
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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