SixFix Hexapod Fixator Hardware and Software Cleared by FDA

The FDA has cleared AMDT Holdings, Inc.’s hexapod fixator device and an associated version of its deformity analysis and correction software.

SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a multilateral circular external fixation system.

The FDA summary document states the system includes rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.

“The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient’s treatment goals.”

Intended Use

The DACS is intended to be used for “post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions,” according to the FDA documents.

Pre-Assembled Struts

In a May 15, 2019 press announcement, the company said that current hexapod fixators commonly consist of two rings connected by six individually attached adjustable struts. These struts with different lengths, according to the company, can create “significant” complexity in managing inventory, part-selection, and intra-operative ring attachment.

But the SixFix is designed with six struts pre-assembled into one 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,” states the company.

Patented Software

In addition to the hardware, the company says that currently available fixation systems “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 company says its patented software, 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.”

Surgeon Testimonials

Paul Freudigman, M.D., an orthopedic surgeon in the Dallas-Fort Worth, Texas, area, 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,” said Freudigman.

Samir Mehta, M.D., chief of Orthopaedic Trauma and Fracture Service for the University of Pennsylvania Health System, said 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.”