Integra LifeSciences Holdings Corporation announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark Certification from the European Union for the HALLU(R)-LOCK MTP Arthrodesis System. The HALLU(R)-LOCK System features Surfix(R) Locking Technology and is an upgrade of the HALLU(R)-FIX System. Surfix(R) Locking Technology allows the surgeon to place the plate at the optimal distance from the bone and then lock the screws. Integra will feature the HALLU(R)-LOCK MTP Arthrodesis System at the 25th Annual Summer Meeting of the American Orthopaedic Foot & Ankle Society, July 15-18, 2009, Vancouver, BC, Canada.
The HALLU(R)-LOCK System is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint (the joint where the big toe meets the foot), including cases of Hallux Rigidus, severe Hallux Valgus and deformity caused from rheumatoid arthritis.
Bob Paltridge, President of Integra Extremity Reconstruction said, We are very pleased to significantly expand our MTP Arthrodesis product offering through the launch of our next generation HALLU(R)-LOCK System. The HALLU(R)-LOCK products utilize our Surfix(R) Locking technology, which will allow our customers to use a unique locking design with our innovative screw and plating technology.
Extremity fixation is an increasingly large segment of the orthopedic market with growth rates in 2009 expected to be at 13%. Industry sources estimate that more than 300,000 surgical procedures were performed in the United States in 2008 for Hallux Limitus/Rigidus and Hallux Valgus, with an estimated market value of over $150 million. Many of these procedures may be performed by using an MTP arthrodesis plate system such as the HALLU(R)-LOCK System.
The HALLU(R)-LOCK MTP Arthrodesis System will be sold by Integra’s Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair/protection and wound repair.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients every year. Our products are used primarily in neurosurgery, orthopedics, and general surgery. Headquartered in Plainsboro, New Jersey, Integra has research and manufacturing facilities throughout the world.