FH Ortho Gets its Second FDA OK in 2015

French orthopedic firm FH Orthopedics Inc. 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). 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 Orthopedics’ 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,” said 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 of the company’s devices approved by the FDA this year. In March, the company’s Arrow Long Keel Shoulder Glenoid Base also was cleared for use in the United States.

“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 Orthopedics’ newly approved products were shown to surgeons attending the American Academy of Orthopaedic Surgeons annual meeting earlier this year, and will be available to surgeons in the United States beginning July.

Founded in 1964, in Mulhouse, France, FH Orthopedics products are focused on joint reconstruction, ligament repair, biologics, foot and ankle, spine, and trauma surgery. 

The company is looking for rapid growth and expansion in the United States, where it is focused on knee ligament repair and shoulder arthroplasty. There are additional products awaiting approval that will address additional orthopedic treatment areas. The firm’s U.S. headquarters are in Chicago, Ill.