FDA OKs AMDT Holdings’ SixFix Hexapod Fixator Device

AMDT Holdings Inc.—which develops new products to address existing and emerging needs in the extremity market—has gained FDA clearance for its SixFix hexapod fixator device and an associated version of its SixFix deformity analysis and correction software (DACS) application.

Hexapod fixators commonly consist of two rings connected by six individually attached adjustable connectors called struts. Currently available devices utilize multiple struts, each with a different range of lengths, which have to be carefully selected for each individual surgery. These systems can create significant complexity in managing inventory, part-selection, and intra-operative ring attachment.
 
The new SixFix hexapod device introduces a unique design in which the six struts are pre-assembled into one compact unit. The strut assembly unfolds to easily connect to the rings and eliminates difficult strut exchanges by providing a full range of lengths with a single strut design. Eliminating the need to exchange struts simplifies inventory, saves times, and provides for greater patient comfort. The unique single-SKU strut assembly also enables the device to be sterile packaged for ease of use, convenient storage, and efficient portability for diverse case scenarios.
 
Currently available fixation systems also require surgeons to manually measure and input values, many derived from patient radiographs, into optional software in order to create a prescription that will achieve a corrected deformity and a healed fracture. The patented SixFix DACS software from AMDT, which was cleared by the FDA in November 2018, dramatically reduces the time and effort required to generate a prescription detailing the strut adjustments necessary to ultimately correct a deformity.
 
“The SixFix system is truly a medical innovation that can offer advantages to both my patients and me,” said Paul Freudigman, M.D., an orthopedic surgeon in the Dallas-Fort Worth, Texas, area who has treated patients with spatial frames for 20 years. “The total reduction in time and effort pre-operatively, intra-operatively, post-operatively can be remarkable. Even more exciting will be to assess how much the image correction capabilities of the software can improve my outcomes.”
 
Stephen J. Frania, DPM, FACFAS, a surgeon in Mentor, Ohio, who specializes in reconstructive foot and ankle surgery including lower limb deformity correction, said, “Of all the advantages offered by the SixFix technology, time-savings, and efficiency are the benefits that I will realize right away.” He goes on to explain, “The current devices require a great deal of time and manual effort during my clinic hours to measure and record the data necessary to describe the frame and the deformity as represented by their radiographs. I bring these patients in weekly to evaluate the progress of their correction. The time I will save and the improved accuracy when using the SixFix device and software can be significant over these repeat visits.”
 
Samir Mehta, M.D., Chief of Orthopaedic Trauma and Fracture Service for the University of Pennsylvania Health System, who is at the forefront of fracture fixation and deformity correction, also expresses his interest in the benefits the SixFix system provides. “The application of the SixFix hexapod is rapid and straight-forward. The intuitive, graphical nature of the SixFix software reduces my time and effort when treating a deformity. The end result is a deformity correction prescription requiring surprisingly little manual input and time.”
 
The SixFix system was developed by Michael Mullaney, vice president of product development at AMDT, who previously developed a web-based implementation of the forward kinematic solution that solved the challenge of the crooked hexapod frame on a crooked bone. In reference to the SixFix system, he states, “The SixFix device provides sufficient descriptive positional data to the SixFix software to enable us to create an accurate 3D replica of the frame and deformity. We are also able to replicate the correct orientation regardless of how the radiographs are presented. The SixFix device and DACS are far more powerful and accurate tools than my prior deformity correction application as well as more intuitive, faster, and easier-to-use.”
 
AMDT president and CEO Patrick Mullaney said, “While the SixFix software alone represents significant improvements and advantages in ease-of-use to the surgeon, these major benefits will be compounded with the introduction of the truly innovative SixFix hexapod. While we are confident the SixFix innovations will be widely appreciated and accepted by surgeons, we are most excited about the potential positive impact we will have on the patient experience.”