SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM— 510(k) K093056

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K093056 for SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM, Substantially Equivalent on 2009-12-15. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code NPJ
Advisory panel: Orthopedic
Date received: 2009-09-30
Decision date: 2009-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NPJ

product code NPJ

Injury: 258
Total: 258

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.