Cleared Traditional

Hintermann Series H2 Total Ankle System

K240475 · Vilex, LLC · Orthopedic

Dec 2024

Decision

286d

Days

Class 2

Risk

About This 510(k) Submission

K240475 is an FDA 510(k) clearance for the Hintermann Series H2 Total Ankle System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on December 2, 2024, 286 days after receiving the submission on February 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K240475 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2024
Decision Date	December 02, 2024
Days to Decision	286 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110