EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System— 510(k) K180317

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K180317 for EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System, Substantially Equivalent on 2018-05-04. Applicant: Microport Orthopedics, Inc..

Clearance details

Applicant: Microport Orthopedics, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2018-02-05
Decision date: 2018-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.