We are excited to announce that the DYNAMIS Navigation System has received FDA 510(k) clearance. The U.S. Food and Drug Administration cleared the system on January 12, 2026, under 510(k) number K252962. As a result, surgeons can now use navigation with the DYNAMIS Implant System during SI joint fusion surgery and fracture fixation of the pelvis.
What the DYNAMIS Navigation System Includes
The DYNAMIS Navigation System is a set of reusable, manual surgical instruments, including drivers, taps and awls. All of the instruments use stainless steel. They work with the Medtronic StealthStation S8 System, software version 2.1, and the Medtronic NavLock Tracker System.
In addition, the instruments work only with the DYNAMIS Implant System. According to the FDA summary, their purpose is to help surgeons locate anatomical structures in open, minimally invasive or percutaneous procedures.
How Navigation Fits Into SI Joint Fusion
Surgical navigation uses images of the patient’s anatomy, such as CT or fluoroscopy, to show where instruments are during a procedure. For many surgeons, navigation is already part of the daily workflow in spine surgery.
Specifically, its cleared indication covers assisting the surgeon in guiding instrument placement and implant positioning. It applies where stereotaxic surgery may be appropriate. It also requires that a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image.
Navigation compatibility therefore expands how surgeons can use the DYNAMIS Implant System. At the same time, it lets surgeons who rely on navigation keep the workflow they already know.
What This Means for Our Customers
This clearance is a major step in our mission to deliver thoughtfully engineered solutions for modern SI joint procedures. It also reinforces our commitment to building a platform designed to support all of our customers.
According to its Instructions for Use (IFU-SI-01 Rev C), the DYNAMIS Implant System has these indications:
The DYNAMIS® Implant System is indicated for sacroiliac joint fusion for: Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The DYNAMIS® Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.
DYNAMIS® Implant System IFU, IFU-SI-01 Rev C
For complete indications, contraindications and instructions, please see the DYNAMIS Implant System IFU.
Finally, there is more to come as we roll out the next phase of our commercial launch. To learn more about the DYNAMIS Navigation System, please contact our team.
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