CHICAGO–(Business Wire)–FH Ortho, maker of thoughtfully designed orthopedic devices and instruments for surgeons around the world, today announced it has received approval from The U.S. Food and Drug Administration (FDA) to market the CALCAnail® System to treat calcaneus (heel) fractures and subtalar arthrodesis (rear foot fusion surgery) in the United States. The CALCAnail System and technique have been used in Europe since August 2011.
The CALCAnail Orthopedic Arthrodesis Nail is indicated for subtalar arthrodesis in the treatment of patients with:
- Comminuted fractures of the calcaneus
- Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae
- Osteoarthritis of the posterior subtalar joint, or
- Valgus flatfoot deformities
“The CALCAnail System allows surgeons to employ an innovative reduction technique that reduces surgical trauma and the risk of complications,” said Jim Hook, Managing Director of FH Ortho’s U.S. operations. “Surgeons use a through-the-heel approach, with a hollow reamer to tunnel into the calcaneus, making it possible to correct calcaneal tuberosity displacements and obtain good reduction of the joint for intra-articular fractures that are composed of large fragments.”
Harnessing a minimally-invasive, closed technique that uses a nail and cannulated screws, the CALCAnail System is indicated for repair of displaced intra-articular fractures of the calcaneus, but also subtalar arthrodesis following intra-articular fracture of the calcaneus (subtalar osteoarthritis and malunion) or degeneration of the subtalar joint.
“In laymen’s terms, there are 120,000 rear foot/heel fractures a year in the United States, about half of which require surgery,” points out Hook. “With this approval, surgeons have another option for giving their patients a minimally invasive repair that holds their heel together so it can heal correctly.”
This is the second FH Ortho device approved by the FDA this year. In March, the Company’s Arrow Long Keel Shoulder Glenoid Base was cleared for use in the U.S.
“We are seeing quick action to approve our device applications, which speaks to the quality of the science that supports our submissions, as well as the thoughtful and efficient design that goes into all FH Ortho products,” added Hook. “We make a conscious choice to design surgical products that are elegant in their simplicity, and distinguished by their flexibility.”
FH Ortho’s newly approved products were shown to surgeons attending the recent American Academy of Orthopaedic Surgeons Annual Meeting in Las Vegas, and will be available to surgeons in the United States beginning July 2015.
