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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 K213781
Device Name ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
DePuy Ireland UC
Ringaskiddy,  IE
Applicant Contact Erin Combs
DePuy Orthopaedics. Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Hannah Foley
Regulation Number888.3565
Classification Product Code
Subsequent Product Code
Date Received12/03/2021
Decision Date 01/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls