“A key step towards establishing a new future standard in spine surgery”
HORSHAM, Pa., Nov. 10, 2025 /PRNewswire/ — OrtoWay-US Inc, the American-German medical technology innovator focused on spine surgery tools for orthopedic spinal separation, today announced the publication of the first multicenter prospective clinical study evaluating its OrtoWell® Distractor System, the world’s first hydraulically powered spinal distractor.
Unique and safe tool for surgeons.
Unlike conventional instruments such as mallets or torque-based retractors, the OrtoWell® system uses a hydraulic mechanism that allows surgeons to open vertebrae gently and safely, with finely controlled incremental pressure. This precise and stable control helps reduce the risk of excessive distraction, complications or neuronal damage, leading to safer and more predictable surgical results.
The study, published in Medical Devices: Evidence and Research (Dove Medical Press, October 2025) and available in summary on PubMed, confirms the safety, usability and intraoperative performance of the device in 30 patients treated in Germany. The results showed no complications related to the device, and surgeons received consistent positive feedback regarding precision, stability, and control.
Smoother, more controllable focus
“The data confirms what surgeons have long reported: that hydraulic distraction offers a gentler, more controllable approach to spinal separation than mechanical systems,” said Stan Mikulowski, CEO of OrtoWay-US Inc. “The OrtoWell® distractor offers surgeons a new level of tactile precision, helping to reduce procedural risk while improving predictability in spinal reconstruction. This is a key step in setting a new future standard in spinal surgery. column”.
Evidence-Based Advancement
Conducted between 2018 and 2023 at three independent German spine centers (Bonn, Essen and Tutzing) and led by Professor Robert Pflugmacher at the Clinic and Polyclinic for Orthopedics and Trauma Surgery at the University of Bonn, the study demonstrated that controlled hydraulic distraction can significantly improve the surgeon’s ability to achieve precise alignment and fixation.
Avoiding complications
In all 30 cases, the OrtoWell® Distractor simplified complex spinal procedures and helped maintain stable patient parameters throughout the surgery. The researchers observed that the system provided safer and more predictable control compared to traditional mechanical tools, reducing the risk of retractor slippage or destruction of cortical walls. Such complications may make preservation of motion impossible and, as a last resort, require spinal fusion surgery.
Precision engineering meets clinical reality
The OrtoWell® Distractor System provides controlled, incremental hydraulic separation and fixation of the vertebral bodies, allowing precise placement of prostheses or cages while maintaining soft tissue protection and optimal visibility. It supports multiple accesses (anterior, lateral, oblique) and is suitable for use in degenerative, traumatic and tumor-related pathologies.
Manufactured in Tuttlingen, Germany, under ISO 13485:2016 certification, the system is approved for use in the US for all types of prosthetics. The underlying technology is protected by US Patent No. 12.023017 B1: Apparatus, Methods and Systems for Spine Surgery.
Previous Documented Applications
The study builds on previous work led by Dr. Biren Desai from the Dreifaltigkeits-Krankenhaus Clinic in Cologne, which documented for the first time a successful multilevel corpectomy using the OrtoWell® system.
“Hydraulic control not only reduces the risk of spinal damage, it transforms the surgical workflow,” Mikulowski added. “We see this as the beginning of a broader shift toward more ergonomic and precision-based surgical tools.”
About OrtoWay-US Inc.
OrtoWay-US Inc. is a privately held German-American medical technology company that develops hydraulic solutions that improve safety and precision in spine surgery. Founded by experts in biomaterials, spine surgery and MedTech engineering, OrtoWay is the developer of the OrtoWell® distraction system, the first hydraulic device designed for controlled spinal separation and fixation.
Headquartered in Horsham, Pennsylvania, and with operations in Tuttlingen, Germany, the company has FDA clearance (Class I) and a portfolio of US patents. OrtoWay-US Inc. is advancing the field of minimally invasive spine technology and actively seeking strategic partnerships to support clinical adoption and global commercialization.
More information: www.ortoway-usa.com
Photo: https://mma.prnewswire.com/media/2817060/OrtoWell_Distractor_System.jpg
SOURCE OrtoWay-US Inc.
