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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 K202194
Device Name ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology
DePuy Ireland UC
Loughbeg Ringaskiddy
Co. Cork,  IE
Applicant Contact Erin Combs
DePuy Orthopaedic, Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Kathy Boggs
Regulation Number888.3565
Classification Product Code
Subsequent Product Code
Date Received08/05/2020
Decision Date 11/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls