Orthofix International N.V. announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its new internal fixation system, the G-Beam™ Fusion Beaming System.
Designed primarily for the treatment of Charcot foot, a debilitating condition where the bones in the foot weaken and collapse, the G-Beam devices can be implanted in the medial and lateral columns of the foot to provide alignment, stabilization and fixation.
“In my practice I often see patients whose uncontrolled diabetes has led to the development of Charcot foot, an extremely disabling condition that if left untreated, can lead to amputation,” said Dr. William Grant, a podiatric surgeon from Virginia Beach, VA who designed the G-Beam system. “Using the G-Beam system allows us to anatomically realign the foot; enabling the bones to heal so these patients can return to a more normal independent lifestyle.”
When the use of internal fixation is recommended, the G-Beam system is designed to fuse the medial and/or lateral columns, as well as bones in the hindfoot, in order to restore a stable foot that may ultimately reduce the probability of an amputation. The system comes with single-use, sterile-packed implants and an efficient, compact instrumentation tray.
“The G-Beam Fusion Beaming System is the next step in working towards our objective of becoming a recognized premium solution provider in the Charcot and Diabetic foot market segments,” said Davide Bianchi, President of the Extremity Fixation business unit. “This system will allow us to establish ourselves in the internal fixation segment of Charcot treatment options, while leveraging our existing product lines, like TrueLok™ and the TL-HEX™.”
