# K171004: Hintermann Series H2 Total Ankle System

- Pathway: 510(k) (Traditional)
- Applicant: Dt Medtech, LLC
- Decided: Nov 7, 2017 after 217 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: 7 generations back to K920802 (1992). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151459: Integra Total Ankle Replacement System, Ascension Orthopedics (2015) Summary page 4.
- K051023: Topez Total Ankle Replacement, Topez Orthopedics, Inc. (2005) Summary page 4.
- K100886: Inbone II Total Ankle Replacement, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K123059: Inbone ( I and II) Total Ankle Systems, Wrightmedicaltechnologyinc (2013) Summary page 4.
- K133585: Inbone Total Ankle, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K060544: Salto Talaris Total Ankle Prosthesis, Tornier (2006) Summary page 4.
- K090076: Salto Talaris Total Ankle Prosthesis, Tornier (2009) Summary page 4.
- K130533: Salto Talaris Total Ankle Prosthesis, RHS, Tornier S.A.S. (2013) Summary page 4.
- K153452: Salto XT, Salto Talaris, Tornier S.A.S. (2016) Summary page 4.
- K152217: Exactech Vantage Total Ankle System, Exactech, Inc. (2016) Summary page 4.

## Most influential descendants
- K240475: Hintermann Series H2 Total Ankle System (2024), 0 descendants of its own
- K230462: OPTIX H2 Patient Specific Instrument System (2023), 0 descendants of its own

## Indications for use
The Hintermann Series H2 Total Ankle Replacement (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/K171004
Methodology: https://510kreport.com/methodology