A New Era in Spinal Surgery: Breakthrough Study of OrtoWell® Hydraulic Distractor System

Enhancing Spinal Surgery with OrtoWell® Hydraulic Distractor System

A recent clinical study has shed light on the OrtoWell® Hydraulic Distractor System, a groundbreaking tool developed by OrtoWay-US Inc, a German-American MedTech company. This innovative device is set to redefine spinal surgery, offering enhanced safety and precision for orthopedic operations. Published in the October 2025 issue of Medical Devices Evidence and Research, the study evaluated the device's performance across 30 patients treated in Germany.

What is the OrtoWell® Distractor System?

The OrtoWell® Distractor stands out as the first hydraulically powered vertebral distractor. Unlike traditional surgical instruments such as mallets or torque-retractors that often apply force mechanically, creating potential for complications, the OrtoWell® is designed to operate with a hydraulic mechanism that provides controlled, smooth, and incremental pressure during vertebral separation. This advancement not only minimizes the risk of over-distraction and neural damage but also leads to more reliable surgical outcomes.

Clinical Study Overview

The study spans from 2018 to 2023, conducted at three renowned spine centers in Germany—Bonn, Essen, and Tutzing. Led by Professor Robert Pflugmacher from the University of Bonn, it aimed to document the safety and usability of the OrtoWell® system. Impressively, there were no complications reported, and surgeons expressed positive feedback regarding its precision and stability.

Benefits of Hydraulic Distraction

Stan Mikulowski, CEO of OrtoWay-US Inc., illustrated the data's significance, stating "Hydraulic distraction offers a gentler, more controllable method of vertebral separation compared to mechanical systems." This innovative approach not only aids surgeons in achieving accurate alignment and fixation but also decreases the likelihood of complications that could necessitate spinal fusion, which often poses a considerable risk.

Controlled and Predictable Outcomes

The performance of the OrtoWell® Distractor proved instrumental in facilitating complex spinal procedures while maintaining patient stability. By allowing for safer and more predictable control, the tool effectively addresses common issues faced with traditional instruments, such as the slippage of retractors that can lead to serious complications.

Technological Advantages

Manufactured in Tuttlingen, Germany, under rigorous ISO certification, the OrtoWell® system supports multiple surgical access approaches and is approved for various types of prostheses in the US. The hydraulically controlled separation of vertebral bodies not only enhances procedural safety but also preserves surrounding soft tissues and optimizes visibility, critical factors in successful spinal surgeries.

OrtoWay's distribution of advanced medical technology is underscored by its robust patent portfolio, including U.S. Patent No. 12,023017 B1, which safeguards the innovative surgical methods offered through the OrtoWell® system.

Looking Forward: A Shift in Surgical Techniques

With the emergence of the OrtoWell® HYDRAULIC DISTRACTOR SYSTEM, a shift towards more ergonomic and precision-focused surgical tools is on the horizon. Mikulowski emphasized that the impact of hydraulic control reaches beyond injury prevention; it revolutionizes the surgical workflow and signifies a new era in spinal surgery practices.

About OrtoWay-US Inc.

OrtoWay-US Inc. is a pioneering medical technology company committed to improving the safety and accuracy of spinal surgeries. With a foundation built on expertise in biomaterials and spinal surgery engineering, they continue to advance minimally invasive techniques and foster collaboration for clinical adoption and global commercialization. For more information, visit www.ortoway-usa.com.