Product Overview
Available for use in the US market
Key Features & Benefits
• Anatomic design of components
• Complete offering of sizes, each available in right or left orientation
• Size matched UHMWPE inlay assembly in 4 different thicknesses and anterior/posterior/neutral offsets
• Designed to provide optimal contact area at all bone-implant interfaces
• Intended to offer anatomic loading (non-stress shielding) at both bone-implant interfaces
• Tibial and talar components are designed with a Plasma Titanium coating intended for cemented use only
• Intuitive, reliable, and clinically-validated state-of-the-art instrumentation
Component Sizing
Tibial Implant Component:
• Sizes 2 – 6 in right or left orientation
Talar Implant Component:
• Sizes 1 – 6 in right or left orientation
PE Inlay:
• Sizes 1-6 in right or left orientation
• Four thicknesses (5, 6, 7, and 9 mm)
• Three offsets (anterior, posterior, and neutral)
Description
The Hintermann Series H2® Total Ankle Replacement prosthesis (Hintermann Series H2®) is a semi-constrained, total ankle replacement system consisting of a talar component, tibial assembly component, and a PE inlay assembly component. Professor Beat Hintermann developed the Hintermann Series H2® based on his more than 18 years of experience implanting his successful H3 ankle outside the US. Prof. Hintermann saw a need to develop a semi-constrained implant designed to address ankle instability and provide reproducible clinical results for the foot and ankle surgeon. After implantation, the Hintermann Series H2® is constrained in a patient-specific optimized position to further support the surrounding tissues, providing stability against translational and rotational forces of the normal ankle joint. This device utilizes the identical surgical preparation and approach as the Hintermann Series H3™, including the instrumentation.
The Hintermann Series H2® talar component is anatomically shaped (conical surface) and is designed to allow for physiological talar motion through eversion with dorsiflexion and to minimize medial ligament stress. The medial and lateral rims help to guide movement of the PE assembly and the anterior pegs help improve sagittal stability and positioning.
The Hintermann Series H2® tibial assembly includes a tibial slide and tray. This piece has a low profile anterior shield which is intended to provide rotational stability of the component and to prevent scarring and bone formation that may hinder joint motion. The superior peaks are designed to provide anchoring in the subchondral bone to increase stability in translation and rotation. The tibial slide is inserted into the tibial tray to fix the anterior/posterior/neutral position of the poly inlay, while still allowing internal/external rotation until the surgeon has determined the proper final alignment of the reconstructed ankle. Once the proper alignment is found, the locking screw must be tightened to fix the rotational aspect of the implant.
The PE inlay assembly is composed primarily of ultra-high molecular weight polyethylene (UHMWPE) and consists of four sub-components which come pre-assembled. The inlay is designed to be inserted into the tibial assembly from the anterior side and is available in three offsets (anterior, posterior, and neutral) to allow the surgeon to correctly reconstruct the ankle and ensure proper alignment between the tibia and talus.
Primary and Revision Surgery
The Hintermann Series H2® Total Ankle Replacement System is indicated 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), and 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 ankle arthrodesis, provided sufficient bone stock is present. In the US, the Hintermann Series H2® is intended for cemented use only.
(https://www.dtmedtech.com/products/united-states-us/h2-ankle-us/)
