FH Ortho Gains FDA 510(k) Clearance for Orthopedic Arthrodesis Nail
FH Ortho has secured FDA 510(k) clearance to market its Calcanail system for heel fractures and rear foot fusion surgery in the U.S, the French devicemaker said Monday.
The orthopedic system uses a technique that decreases surgical trauma and complication risk, says Jim Hook, managing director of FH Ortho’s U.S. operations. Surgeons employ a through-the-heel approach, using a hollow reamer.
The system can also be used to counteract subtalar joint degeneration.
This is the company’s second device to be FDA-cleared this year. FH Ortho’s Arrow long keel shoulder glenoid base was approved in March. The Calcanail system has been available in Europe since 2011.
The product will be available to U.S. surgeons next month. — Jason Scott