Hintermann Series H2 Total Ankle System— 510(k) K240475

Name: FDA 510(k) clearance K240475
Creator: U.S. Food and Drug Administration
Published: 2024-12-02

Substantially Equivalent

Vilex, LLC

FDA 510(k) clearance K240475 for Hintermann Series H2 Total Ankle System, Substantially Equivalent on 2024-12-02. Applicant: Vilex, LLC. Device class: 2.

Clearance details

Applicant: Vilex, LLC
Product code: Code HSN
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2024-02-20
Decision date: 2024-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, TN, US

Download summary PDF View on FDA.gov ↗

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K250641 — APEX 3D Total Ankle Replacement System2025-05-01
K241999 — Prophecy Surgical Planning System2024-11-01

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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.