Ortho Kinematics KineGraph Vertebral Motion Analyzer System Receives FDA Clearance

Ortho Kinematics has received FDA clearance for its KineGraph Vertebral Motion Analyzer (VMA) system. The KineGraph VMA system is designed to standardize and automate the processes involved with flexion/extension X-rays, including patient bending, image acquisition and image analysis. Motion Normalizer devices provide powered passive trunk bending in either a standing or lying down configuration. Fluoroscopy images of the spine are then captured at standardized trunk bending angles. Image recognition software locates the vertebrae on each frame and the intervertebral angle is plotted as a function of the degree of trunk bending, creating a KineGraph plot for each vertebral level. From the press release:

Flexion/Extension x-rays have remained the standard for quantifying spine function for over 60 years. The standard test provides only a rough approximation of spine function because it compares measurements, taken from X-ray images, of patients standing upright versus bending backward, forward, and sideways. The KineGraph VMA involves patented refinements that allow surgeons to view videos of vertebral motion that cover the entire range of spine bending instead of comparing just two x-ray “snapshots”.

In addition, a much more expansive set of biomechanical measurements are produced and overlaid on the video images. By delivering a more complete and actionable diagnostic dataset, the KineGraph VMA can support more informed treatment decisions. This can all be accomplished without increasing the radiation exposure to the patient.

The company expects to make the KineGraph VMA commercially available in the United States starting in February, initially limiting access to a select group of the largest U.S. spine specialty hospitals.

Press release: Ortho Kinematics Receives FDA 510(k) Clearance for KineGraphVMA System…

Product page: KineGraph VMA…