JOURNEY II Unicompartmental Knee System— 510(k) K191211

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K191211 for JOURNEY II Unicompartmental Knee System, Substantially Equivalent on 2019-07-25. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 2019-05-06
Decision date: 2019-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.