# K252962: DYNAMIS™ Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Promethean Restorative, LLC
- Decided: Jan 12, 2026 after 118 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K040583 (2004). 195 ancestors in all.
No later device cites it as a predicate yet.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181606: Precision Spine Navigation Instrumentation, Precision Spine, Inc. (2019) Summary page 5.
- K210637: CD Horizon™ Spinal System, Medtronic (2021) Summary page 5.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K250182: Innovasis Navigation Instruments, Innovasis, Inc. (2025) Summary page 5.

## Indications for use
The DYNAMIS™ Navigation System is intended to be used in the preparation and placement of the DYNAMIS™ Implant System during sacroiliac joint fusion surgery and fracture fixation of the pelvis to assist the surgeon in guiding instrument placement and implant positioning, in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis, or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image based model of the anatomy. The DYNAMIS™ Navigation System is intended to be used with the Medtronic StealthStation S8 System, Software Version 2.1.

Source page: https://510kreport.com/device/K252962
Methodology: https://510kreport.com/methodology