Kinos Total Ankle System— 510(k) K252454

Substantially Equivalent

Restor3D

FDA 510(k) clearance K252454 for Kinos Total Ankle System, Substantially Equivalent on 2025-09-03. Applicant: Restor3D.

Clearance details

Applicant: Restor3D
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 2025-08-04
Decision date: 2025-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

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.