EVOLUTION® Hinge Knee System— 510(k) K230563

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K230563 for EVOLUTION® Hinge Knee System, Substantially Equivalent on 2023-09-27. Applicant: Microport Orthopedics, Inc..

Clearance details

Applicant: Microport Orthopedics, Inc.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2023-03-01
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.