510(k) K170288

BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell by Microport Orthopedics, Inc. — Product Code MBH

K170288 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell". The FDA issued a decision of Substantially Equivalent on Jun 15, 2017. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Microport Orthopedics, Inc. has 38 other 510(k) clearances on record.