The 510(k) clearance of accessories for the SixFix® Circular Fixation System improves versatility and ease-of-use

Saturday, September 26, 2020

AMDT Holdings, Inc. develops disruptive products to address existing and emerging needs in the extremity market. The flagship products for AMDT Holdings are the patented SixFix® Circular Fixation System, the patented SixFix Deformity Analysis and Correction Software, and the patented AMDT Mini-Rail.

The SixFix Circular Fixation System is a platform that can address extremity applications in trauma, foot and ankle, and deformity correction for both adults and pediatrics. The SixFix strut assembly unfolds to easily connect the rings and eliminates difficult strut exchanges by providing a full range of lengths with a single strut design.

Surgeons continue to increase their use of software to enhance the effectiveness of implant technologies. An advanced component of the SixFix System is the optional, patented software enabling deformity analysis and correction with the surgeon input limited to only known values such as ring size and strut length. The software is also able to correct for non-orthogonal radiographs, perspective distortion and variations in radiograph focal point – all of which introduce errors into the common radiograph. The software converts the two 2D radiographic images into accurate 3D depictions of both frame and deformity. The resulting prescription removes radiographic inaccuracies that may contribute to residual deformities.

Even a system as unique and advanced as the SixFix benefits from optional accessories. These devices expand the range of possible constructs to meet the patient's needs that in some instances may not necessarily require the extraordinary capabilities of the best technology the SixFix Circular Fixation System has to offer. These include Reduction Struts with lockable universal ball joints at both ends offering acute adjustment and incremental compression or distraction. The Foot Ring with Locking Hinges provides angular adjustment as it pivots around a specific axis and makes the foot ring more resistant to the bending forces produced by wires under tension. Another hinge device can connect two supports at almost any angle, can create a hinge construct or be used to reinforce a foot and ankle frame by connecting the foot arch to a tibial ring. A one-piece half-pin fixation clamp directs a half-pin straight from the ring to the bone at a variety of angles either superior or inferior to the ring.