Treace Medical Concepts (TMC) Compression Screw System— 510(k) K172617

Substantially Equivalent

Treace Medical Concepts, Inc.

FDA 510(k) clearance K172617 for Treace Medical Concepts (TMC) Compression Screw System, Substantially Equivalent on 2017-10-25. Applicant: Treace Medical Concepts, Inc..

Clearance details

Applicant: Treace Medical Concepts, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2017-08-31
Decision date: 2017-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ponte Vedra Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.