FDA clears AMDT Holding’s SixFix external fixator

ADMT Holdings has received FDA clearance for its SixFix hexapod fixation device and its deformity analysis and correction software.

Hexapod fixations feature two rings that are connected by six individually attached adjustable connectors known as struts. There are devices currently available that use multiple struts with different lengths. Each strut has to be carefully chosen for different surgeries, which can cause problems in managing inventory, part-selection and intra-operative ring attachment.

The SixFix hexapod device features six pre-assembled struts in one unit. The assembly can be unfolded to easily connect rings while eliminating difficult strut exchanges with a full range of lengths in a single strut design. The system also eliminates the need to exchange struts, which can simplify inventory, save time and have greater patient comfort, according to the company. Hexapod devices have a single-SKU strut assembly that allows the device to be sterile-packaged for easier use, convenient storage and efficient portability for diverse cases.

“The SixFix system is truly a medical innovation that can offer advantages to both my patients and me,” said Dr. Paul Freudigman, an orthopedic surgeon 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.”

SixFix DACS software also helps doctors reduce the time and effort needed to make a prescription detailing the strut adjustments needed to correct deformities.

“Of all the advantages offered by the SixFix technology, time-savings, and efficiency are the benefits that I will realize right away,” said Dr. Stephen Frania, a surgeon who specializes in reconstructive foot and ankle surgery. “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.”