BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

MicroPort Orthopedics, Inc.

The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for Biofoam® Additive Manufacturing (biofoam® Am), Advance® Biofoam® Tibial Base, Evolution® Biofoam® Tibial Base, Dynasty® Biofoam® Acetabular Shell.

Pre-market Notification Details

• Device ID: K170288
• 510k Number: K170288
• Device Name: BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002
• Contact: Grace Johnson-bann
• Correspondent: Grace Johnson-bann; MicroPort Orthopedics, Inc. 5677 Airline Road Arlington, TN 38002
• Product Code: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-30
• Decision Date: 2017-06-15
• Summary: summary