AMDT Gains 510(k) clearance for SixFix Circular Fixation System Accessories

By Julie A. Vetalice

AMDT Gains 510(k) clearance for SixFix Circular Fixation System Accessories

AMDT gained FDA 510(k) clearance for additional accessories for use with the SixFix® Circular Fixation System, used for extremity applications in trauma, foot and ankle, and deformity correction for adults and pediatrics. Initial clearance was granted in 2019, and the system launched in early 2020.

The SixFix strut assembly unfolds to connect the rings and is designed to eliminate difficult strut exchanges by providing a range of lengths with a single strut design.

SixFix features an optional software to enable deformity analysis and correction with the surgeon input limited to only known values such as ring size and strut length. The software can also correct for non-orthogonal radiographs, perspective distortion and variations in radiograph focal point. The software converts 2D radiographic images into 3D depictions of the frame and the deformity.

Optional accessories expand the range of possible constructs to meet anatomic variations. 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 and makes the foot ring more resistant to bending forces. Another hinge device can connect two supports at almost any angle, can create a hinge construct or 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.

Product Labels: External Fixation

Tags: 510(k) Clearance, Regulatory