FH Ortho wins FDA 510(k) clearance for Calcanail

FH Ortho said today that it won FDA 510(k) clearance for its Calcanail system designed for rear-foot fusion therapy to repair displaced intra-articular fractures of the heel.

The system is minimally invasive and uses a nail and cannulated screws to repair rear foot or heel fractures, the Mulhouse, France-based company said.

“The Calcanail System allows surgeons to employ an innovative reduction technique that reduces surgical trauma and the risk of complications. 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,” U.S. managing director Jim Hook said in a press release.

“In laymen’s terms, there are 120,000 rear foot/heel fractures a year in the United States, about half of which require surgery. 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,” Hook said.

The Calcanail is indicated for rear-foot fusion therapy for patients with comminuted fractures of the heel, post-traumatic osteoarthritis, poor function resulting from calcaneal fracture sequelae, osteoarthritis of the posterior subtalar joint and valgus flat foot deformities, the company said.

“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,” Hook said. “We make a conscious choice to design surgical products that are elegant in their simplicity, and distinguished by their flexibility.”

FH Ortho said the system will be available to surgeons in the United States beginning July 2015.

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