FH Ortho Receives FDA Marketing Approval for CALCAnail

FH Ortho has announced the receipt of approval from FDA to market the CALCAnail System to treat calcaneus fractures and subtalar arthrodesis (rear foot fusion surgery) in the U.S.

“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, in the June 15, 2015 news release. “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.”

The CALCAnail System involves a “minimally-invasive, closed technique that uses a nail and cannulated screws….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.”

“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.”

OTW asked Jim Hook: “The word ‘thoughtful’ seems to be important for your company. Is there a ‘backstory’ here?”

Hook replied, “‘Thoughtful’ is a key development philosophy for FH Orthopedics. Our development teams spend many, many hours with the global surgeon community to learn the challenges presented by patients who require both elective and in some cases non elective surgical intervention. Each series of cases provides FH Ortho with invaluable insight that when employed enhances product innovation and outcomes. We strive to bring creative and thoughtful solutions to orthopedic surgeons in the global environment we serve. This is the essence our company DNA. Products within the FH Ortho portfolio are founded in the strong scientific method of observation, thoughtful questioning, solid engineering and eventual commercialization.”

“Sales of the CALCAnail are expected to exhibit rapid acceptance in the U.S. Market. The product has a significant clinical utilization in Western medicine and has demonstrable clinical outcomes. U.S. distribution is now being expanded for the planned introduction of an entire range of foot and ankle products. The innovative CALCAnail will be the lead product to be introduced in the U.S. followed by a complete new line of plates, screws, wedges and MIS surgical instruments. Additional products are under active development with notable foot and ankle surgeons in the U.S. and Europe.”