Hintermann Series H3®

Total Ankle Replacement System

(Available for use in the US market)

The Hintermann Series H3® Total Ankle Replacement System (Hintermann Series H3) is a non-constrained, three-component total ankle replacement system approved by the FDA. The Hintermann Series H3 is indicated for use as a primary non-cemented implant to replace a painful arthritic ankle joint due to:

  • Primary osteoarthritis
  • Post-traumatic osteoarthritis
  • Arthritis secondary to inflammatory disease

The Hintermann Series H3 Total Ankle Replacement System, also referred to as the H3, is intended to replace the ankle joint in primary surgeries. The device permits four degrees of freedom, providing an unconstrained tibial articulating surface and a semi-constrained talar articulating surface for anteroposterior translation, mediolateral translation, tibial rotation, and dorsi/plantar flexion movement. The Hintermann Series H3 consists of a tibial implant component, a talar implant component, and an ultra-high molecular weight polyethylene mobile bearing insert (PE inlay).

The tibial implant is manufactured from cobalt chromium and is designed as a bone-sparing device. It resurfaces the tibia with a large flat surface to provide a physiological load transfer and minimal contact stress to the bone. There are pyramidal peaks for anchoring in the subchondral bone thus increasing stability in translation and rotation.

The talar implant is manufactured from cobalt chromium and has an anatomical shape (frusto-conical surface) which is designed to allow physiological articulation and minimize medial ligament stresses. The medial and lateral rims are provided on each side of this implant, which are designed to guide movement of the PE inlay and to provide flexion stability to the construct. A flat cut talar option is available for patients with less bone stock.

The Polyethylene (PE) Inlay is manufactured from ultra-high molecular weight polyethylene with a high congruency with the metal surfaces of both tibial and talar components. The PE inlay allows unconstrained rotatory gliding (sagittal and frontal plane) on the flat tibial surface with a semi-constrained free sagittal plane motion on the anatomical conically-shaped talar. This component is designed to have a large contact area with the tibial and talar components to minimize contact stresses and wear, and to provide intrinsic stability against eversion-inversion forces. The PE inlay also includes titanium x-ray markers.

Key Features & Benefits

  • 18 years of clinical history outside of the US with a documented 88% survivorship at 7 years1
  • Complete offering of six sizes for both metallic components
  • Size-matched PE inlay available in 4 different thicknesses
  • Tibial and talar components are coated with titanium plasma and hydroxyapatite (HaP) for uncemented or biological fixation
  • Anatomic design of components
  • Designed to provide optimal contact area at all bone-implant interfaces
  • Intended to offer anatomic loading (non-stress shielding) at both bone-implant interfaces
  • Low profile instruments, designed by surgeons, for ease of use, speed, and consistent reproducibility

1 https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160036b.pdf

Component Sizing

Tibial Implant Component:
Sizes 1 – 6 in right or left orientation
Talar Implant Component:
Sizes 1 – 6 in right or left orientation
Flat Talar Implant Component:
Sizes 1 – 5 in right or left orientation
PE Inlay:
Sizes 1 – 6 as well as thicknesses of 5, 6, 7 and 9mm