# K183630: SPINEART Navigation Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Jun 10, 2019 after 166 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: 17 generations back to K040583 (2004). 155 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K172517: SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2018) Summary page 5.
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 5.

## Most influential descendants
- K210472: SPINEART Navigation Instrument System (2021), 5 descendants of its own
- K242890: SPINEART Navigation Instrument System (2025), 3 descendants of its own
- K241644: SPINEART Navigation Instrument System (2024), 3 descendants of its own
- K242933: SPINEART Navigation Instrument System (2025), 2 descendants of its own
- K254158: SPINEART Navigation Instrument System (2026), 1 descendant of its own

## Indications for use
The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Source page: https://510kreport.com/device/K183630
Methodology: https://510kreport.com/methodology