EVOLUTION UNICONDYLAR KNEE SYSTEM— 510(k) K100973

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K100973 for EVOLUTION UNICONDYLAR KNEE SYSTEM, Substantially Equivalent on 2010-08-10. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2010-04-08
Decision date: 2010-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.