Promethean Restorative, LLC · Class II · Cleared Jan 12, 2026
| K-number | K252962 |
| Device name | DYNAMIS Navigation System |
| Applicant | Promethean Restorative, LLC |
| Product code | OLO |
| Device class | Class II |
| Decision date | Jan 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
The DYNAMIS™ Navigation System is a set of reusable stainless steel surgical instruments (drivers, taps, awls) designed for use with the Medtronic StealthStation® S8 navigation system. It assists surgeons in guiding instrument placement and implant positioning during sacroiliac joint fusion surgery and pelvic fracture fixation by registering with preoperative CT, MR, or fluoroscopic images.
The system consists of non-sterile, reusable manual surgical instruments made of stainless steel per ASTM F899. The instruments are designed for exclusive use with the Medtronic StealthStation® System S8 and Medtronic NavLock® Tracker System and are not compatible with implants from other manufacturers.
ASTM F899 (stainless steel material specification). The document does not cite ISO or IEC consensus standards for navigation accuracy or performance.
The DYNAMIS™ Navigation System is substantially equivalent to predicate devices (primarily Precision Spine Navigation System K181606) based on identical indications for use, same technological characteristics in design, materials, and function, and performance testing demonstrating adequate registration with the navigation system and appropriate fit with previously cleared devices.
View the full FDA submission: accessdata.fda.gov