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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K171966
Device Name Mpact® 3D Metal™ Implants and Augments 3D Metal™
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Mapi USA, Inc.
2343 Alexandria Dirve
Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received06/30/2017
Decision Date 03/27/2018
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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