TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)— 510(k) K251945

Substantially Equivalent

TriMed, Inc.

FDA 510(k) clearance K251945 for TriMed Total Wrist Fusion System (Total Wrist Fusion Plate), Substantially Equivalent on 2025-07-10. Applicant: TriMed, Inc..

Clearance details

Applicant: TriMed, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2025-06-25
Decision date: 2025-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clarita, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.