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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 K170288
Device Name BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
Applicant
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact Grace Johnson-Bann
Correspondent
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact Grace Johnson-Bann
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
LZO  
Date Received01/30/2017
Decision Date 06/15/2017
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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