FH Ortho Receives FDA 510(k) Clearance for Its CALCAnail Orthopedic Arthrodesis Nail
CHICAGO–(BUSINESS WIRE)–FH Ortho, maker of thoughtfully designed orthopedic devices and instruments for surgeons around the world, today announced it 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) in the United States. 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 Ortho’s 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,” points out 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 FH Ortho device approved by the FDA this year. In March, the Company’s Arrow Long Keel Shoulder Glenoid Base was cleared for use in the U.S.
“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 Ortho’s newly approved products were shown to surgeons attending the recent American Academy of Orthopaedic Surgeons Annual Meeting in Las Vegas, and will be available to surgeons in the United States beginning July 2015.
About FH Ortho
FH Ortho makes thoughtfully designed orthopedic devices, instruments and procedures for surgeons around the world. Founded in 1964, in Mulhouse, France, FH Orthopedics products are focused on joint reconstruction, ligament repair, biologics, foot & ankle, spine, and trauma surgery. Backed by 50 years of forward-thinking innovation in not only devices and technique, but even in the way products are shipped, stored and deployed in the O.R., the company is today positioned for rapid growth and expansion in the United States, where FH Ortho is focused on knee ligament repair and shoulder arthroplasty. There are additional products awaiting approval that will address additional orthopedic treatment areas.
Backed by insight that comes from tens of thousands of surgical cases, decades of research and impressive clinical results, FH Ortho products are sought after for their benefit to not only the surgeon and patient, but also to the medical center where the patient is treated.
FH Ortho products are developed and refined by surgeon experts who are among the world leaders in their respective fields. Prized for elegant design and distinguished by clinical sophistication and flexibility, FH products help surgeons deliver ideal patient outcomes with devices, systems and tools that simplify things for the surgeon, at an overall cost structure that is a benefit to the medical center and the community.
With an unrelenting commitment to innovation, research and collaboration, FH continues to bring new ideas and techniques to advance the forefront of orthopedics globally.
Learn more at www.FHOrtho.com.
Source: Business Wire Health
