This is a brief overview of information related to FDA's approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Hintermann Series H3™ Total Ankle Replacement System
PMA Applicant: DT MedTech, LLC
Address: 110 West Road, Towson, MD 21204
Approval Date: June 4, 2019
Approval Letter: Approval Order

What is it?  The Hintermann Series H3™ Total Ankle Replacement System is an implanted medical device intended to replace a painful arthritic ankle joint in the first surgical treatment for the joint (primary surgery). The Hintermann Series H3™ Total Ankle Replacement System is comprised of the following three components:

• Tibial component -  manufactured from cobalt-chrome (CoCr) with a double coating (titanium plasma spray coated with hydroxyapatite) on the bone-contacting surface. It covers the very bottom of the shin bone (tibia), which is also the upper portion of the ankle joint.
• Talar component - manufactured from cobalt-chrome (CoCr) with a double coating (titanium plasma spray coated with hydroxyapatite) on the bone-contacting surface. It covers the lower bone of the ankle joint, the talus.
• Polyethylene Sliding Insert -  manufactured from ultra-high molecular weight polyethylene (UHMWPE).

How does it work?  The implanted device replaces the damaged articulating surfaces of the shin (tibia) and ankle (talus) bones in a painful arthritic ankle joint.

When is it used?  During total ankle replacement surgery, the damaged parts of the ankle joint (tibia and talus) are removed, and the Hintermann Series H3 Total Ankle Replacement is implanted. 

What will it accomplish?  The device is designed to reduce pain and improve motion in the ankle joint. In the clinical data provided, patients receiving the Hintermann Series H3™ Total Ankle Replacement System had fewer serious device-related adverse events (other than a revision or removal) 2 years after surgery than another similar total ankle replacement system.

When should it not be used?  The Hintermann Series H3™ Total Ankle Replacement System is not for patients who have:

• Skeletal immaturity, when the ankle bones are not fully grown
• Poor quality bone that keeps the bone from supporting the implant. Some conditions that cause poor bone quality are
  • Osteoporosis or osteopenia
  • Osteonecrosis of the ankle bone (talus)
• Current or past infection in the ankle joint or the bones next to the ankle
• Poor ankle or knee alignment, poor support from ankle ligaments, or severe deformity of the ankle or nearby bones and joints, which can keep the foot from being flat to the ground
• Neuropathic arthropathy, also known as Charcot joint, which destroys bones and soft tissues or peripheral neuropathy (numbness, weakness, or pain in your ankle and foot) that can cause Charcot joint of the affected ankle, such as from diabetic complications
• Poor muscle function around the ankle
• Not enough blood flowing to the bones of the foot
• Poor skin and soft tissue quality around the surgical area
• Immunosuppressive therapy that decreases the body's ability to fight infection, which may be used to keep a person from rejecting a bone marrow or organ transplant, or to treat autoimmune diseases and allergies
• Prior ankle fusion or a previous total ankle replacement
• High demand sport activities, such as contact sports or jumping
• Suspected or documented metal allergy or intolerance

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data
• Physician Labeling
• Patient Labeling
• PMA Database Entry