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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 K211609
Device Name ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Brad Osborne
Correspondent
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Correspondent Contact Brad Osborne
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received05/25/2021
Decision Date 08/25/2021
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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