EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System

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 Evolution® Knee Systems – Mr Labeling, Evolution® Biofoam® Tibial System, Evolution® Revision Tibial System, Evolution® Revision Cck System.

Pre-market Notification Details

• Device ID: K180317
• 510k Number: K180317
• Device Name: EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
• 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: 2018-02-05
• Decision Date: 2018-05-04
• Summary: summary