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FDA grants 510(k) approval for FH Ortho’s CALCAnail system

Orthopedic devices and instruments maker FH Ortho has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its CALCAnail system to treat calcaneus (heel) fractures and subtalar arthrodesis (rear foot fusion surgery).

CALCAnail System has been developed to repair displaced intra-articular fractures of the calcaneus, as well as subtalar arthrodesis following intra-articular fracture of the calcaneus or degeneration of the subtalar joint.

CALCAnail orthopedic arthrodesis nail is suggested for subtalar arthrodesis to treat patients with comminuted fractures of the calcaneus, post-traumatic osteoarthritis and poor function resulting from calcaneal fracture sequelae, osteoarthritis of the posterior subtalar joint and valgus flatfoot deformities.

FH Ortho US operations managing director Jim Hook 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."

The CALCAnail system, along with the technique, has been used in Europe since August 2011.

In March this year, the company received FDA approval for its Arrow Long Keel Shoulder Glenoid Base.