JOURNEY II XR KNEE SYSTEM— 510(k) K141471

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K141471 for JOURNEY II XR KNEE SYSTEM, Substantially Equivalent on 2014-11-14. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2014-06-03
Decision date: 2014-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cordova, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.