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Integra LifeSciences Receives CE Mark And US FDA Approval For HALLU-LOCK MTP Arthrodesis System

Integra LifeSciences Holdings Corporation has received 510(k) clearance from the US FDA and CE Mark Certification from the European Union for the HALLU-LOCK MTP Arthrodesis System. The System incorporates Surfix Locking Technology, which enables surgeon to place the plate at an optimal distance from the bone and then lock the screws. The System is an upgrade of the HALLU-FIX System. The company will showcase the HALLU-LOCK MTP Arthrodesis System at the 25th Annual Summer Meeting of the American Orthopaedic Foot & Ankle Society in Canada.

The HALLU-LOCK System is intended to be used in fixation of fractures, arthrodesis or osteotomies of the first metatarsophalangeal joint, it also includes the cases of Hallux Rigidus, severe Hallux Valgus and deformity caused from rheumatoid arthritis.

 

We are very pleased to significantly expand our MTP Arthrodesis product offering through the launch of our next generation HALLU-LOCK System. The HALLU-LOCK products utilize our Surfix Locking technology, which will allow our customers to use a unique locking design with our innovative screw and plating technology, said Bob Paltridge, President of Integra Extremity Reconstruction.

 

The HALLU-LOCK MTP Arthrodesis System will be sold by company’s Extremity Reconstruction sales organization.