The OrtoWell® Distractor is the world’s first hydraulically powered system for the separation and fixation of vertebrae during anterior and lateral surgery. Safe, smooth and accurate, this award-winning system is used by leading surgeons for insertion of disc prosthesis, positioning of AILF cages, spinal corpectomy, tumor removal, lateral minimally invasive surgery (MIS), and revision surgery. The device is approved for use in the US (Class 1 Medical Device) and the company has ISO 13 485:2016 approval. It has been successfully used by leading clinics in up to 50 surgeries and has shown strong potential in clinical tests for many aspects of spinal surgery. The OrtoWell Distractor will undergo MDR Certification during the period of 2022-2023.
Precision engineered and manufactured in Germany, the OrtoWell® Distractor is designed with the needs of the modern spinal clinic in mind. Based on input from leading spinal surgeons, it includes the latest materials and design thinking – from the tactile feel of the tools to the caddy setup. The system includes a number of key product components as well tools provided in a caddy system.
Main product components
The Distractor unit, including tube, gauge and spanner unit, are delivered gamma sterilized. These components/parts may not be used after the expiration date of if the packaging is broken nor after clinical use. The components may not be re-sterilized at the clinic and must be returned to OrtoWay or partner for refurbishment along with the caddy and all pistons.
Our tool components are delivered unsterilized and must be autoclaved before use in accordance with autoclavation instructions. Tools and other components include the following:
Our all-new, second generation caddy system is designed to help you avoid digging around for the right instrument and prevent errors. Tools are clearly marked and positioned in a mesh stainless steel tray, while bone screws and other components are slotted into their own accompanying plastic tray holder.
To ensure safe and effective use of the OrtoWell® Distractor, we provide a complete training program with one of our medically certified surgical experts. There is also a step-by-step “Instructions for Use” guide that must be reviewed prior to use. In addition to this, however, we understand that you may want additional support when using the device during surgeries. Many of our team members have worked extensively in the surgical environment and are happy to be at your side, if needed. Our aim is to support you every step of the way to achieve the best patient outcomes.
For ventral surgery, four screws and two Distractors are used. Make notches in the vertebrae with the awl to mark the positions of the screws. The screws are best secured near the end plates of the vertebrae. Ensure sufﬁcient lateral screw distance, to allow the implant to be inserted between the hydraulic cylinders. Have bone wax available in case of bleeding. Angle the screws to avoid penetrating the spinal canal. Note the position and depth of the screws with the X-ray equipment. The screws must enter, but not go through, the opposite cortical bone tissue.
Remove the protective cages from the screws and mount spacer rings of suitable length. Attach the Distractor units on bone screws paired in the longitudinal direction of the vertebral column. Position the Distractor units laterally, away from the middle of the spine. Observe caution with the sympathetic trunk and other nearby nerves and vessels. Cover the tops of the screws with protective caps.
Using the lock screwdriver, fasten the Distractor units vertically. Then lock with all four bone screws.
Use the offset screwdriver to lock the Distractor units at desired angles against the bone screws. The angle may be altered during the operation.
Turn the handles to control pressure and extend pistons in the Distractor units. Alternate between the two Distractor units and increase the pressure incrementally to separate the vertebrae. Monitor the pressure with the built-in pressure gauge.
Replace disc according to regular procedure. Follow instructions and use prosthesis holder and customary tools provided by the manufacturer. Turn the control handles to ﬁne-tune the gap between the vertebrae, as required. OrtoWell® offers superior control of the vertebral distance, ensuring optimal ability to position the prosthesis. Inspect the position of the prosthesis carefully after insertion and re-compression of the vertebral column. If necessary, carefully separate the vertebrae again to make adjustments. Finally, you can remove the Distractor in the reverse direction as the steps above.
“Not only did the OrtoWell® Distractor help simplify the procedure but I was impressed by the very strong, smooth hydraulic action.”
Head of Spine Surgery Department, Dreifaltigkeits-Krankenhaus Clinic, Cologne, Germany