# K240475: Hintermann Series H2 Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Dec 2, 2024 after 286 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K920802 (1992). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171004: Hintermann Series H2 Total Ankle System, Dt Medtech, LLC (2017) Summary page 6.

## Indications for use
The Hintermann Series H2 Total Ankle (Hintermann Series H2) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint. The Hintermann Series H2 is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by: - Systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis) - Primary arthritis (e.g., degenerative disease) - Secondary arthritis (e.g., post-traumatic, avascular necrosis, provided enough of the talus is preserved to support the implant) The Hintermann Series H2 is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided sufficient bone stock is present. Note: In the United States, this device is intended for cemented use only.

Source page: https://510kreport.com/device/K240475
Methodology: https://510kreport.com/methodology