Tornier Humeral Reconstruction System Max (Tornier HRS Max)— 510(k) K251686

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K251686 for Tornier Humeral Reconstruction System Max (Tornier HRS Max), Substantially Equivalent on 2025-10-30. Applicant: Tornier, Inc..

Clearance details

Applicant: Tornier, Inc.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2025-06-02
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.