HORSHAM, PA — OrtoWay-US Inc., a U.S.–German MedTech company specializing in precision spinal surgery tools, has released results from the first prospective, multi-center clinical study evaluating its OrtoWell® Distractor System — the world’s first hydraulically powered vertebral distractor. The peer-reviewed findings, published in Medical Devices: Evidence and Research in October 2025, highlight the device’s potential to reshape surgical practice by offering a more controlled, predictable alternative to mechanical vertebral separation.
Unlike traditional tools such as mallets or torque-based retractors, the OrtoWell system uses a hydraulic mechanism that allows surgeons to gradually open vertebrae with finely calibrated, incremental pressure. The approach is designed to reduce the risk of over-distraction, neural damage, and structural complications that can arise during complex spinal procedures.
The study, conducted from 2018 to 2023 at spine centers in Bonn, Essen, and Tutzing and led by Professor Robert Pflugmacher of the University of Bonn, evaluated 30 patients undergoing various spinal reconstructions. Investigators reported no device-related complications and consistently positive surgeon feedback on the tool’s stability, precision, and intraoperative performance.
“The data confirms what surgeons have long reported — that hydraulic distraction offers a gentler, more controllable approach to vertebral separation than mechanical systems,” said OrtoWay-US CEO Stan Mikulowski. He added that the system’s tactile precision and predictable control could help establish “a new future standard in spinal surgery.”
Researchers noted that the OrtoWell Distractor made complex procedures easier to execute, helping maintain stable patient parameters and reducing risks linked to mechanical systems, such as retractor slippage or cortical wall destruction — complications that can jeopardize motion preservation and ultimately force spinal fusion.
Engineered for precision and safety, the OrtoWell system enables incremental hydraulic separation and fixation of vertebral bodies while protecting soft tissue and retaining surgical visibility. Its design supports multiple surgical approaches — anterior, lateral, and oblique — and can be used for degenerative, traumatic, and tumor-related pathologies. Manufactured in Tuttlingen, Germany under ISO 13485:2016 standards, the system is approved for U.S. use on all prosthesis types and is protected by U.S. Patent No. 12,023017 B1.
The results build on earlier clinical experience from Cologne’s Dreifaltigkeits-Krankenhaus Clinic, where surgeons documented successful multi-level corpectomy procedures using the tool.
“Hydraulic control not only reduces the risk of vertebral damage — it transforms the surgical workflow,” Mikulowski said, noting that growing interest from international centers signals a broader shift toward more ergonomic and precision-based surgical instruments.
As demand for safer, minimally invasive spinal solutions grows, the OrtoWell system’s early clinical validation positions it as a promising advance in orthopedic and neurosurgical care.
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