# K254158: SPINEART Navigation Instrument System

- Pathway: 510(k) (Special)
- Applicant: Spineart SA
- Decided: Apr 9, 2026 after 108 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: 21 generations back to K040583 (2004). 215 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212245: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning, Brainlab AG (2022) Summary page 5.
- K201189: Stealthstation S8 Spine Software v1.3.0, Medtronic Navigation, Inc. (2020) Summary page 5.
- K183630: SPINEART Navigation Instrument System, Spineart SA (2019) Summary page 5.
- K210472: SPINEART Navigation Instrument System, Spineart (2021) Summary page 5.
- K241644: SPINEART Navigation Instrument System, Spineart SA (2024) Summary page 5.
- K242933: SPINEART Navigation Instrument System, Spineart SA (2025) Summary page 5.

## Most influential descendants
- K261205: SPINEART Navigation Instrument System (2026), 0 descendants of its own

## Indications for use
The SPINEART Navigation 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 reusable instruments are specifically designed for use with the Medtronic® StealthStation® System and the Brainlab® Spine & Trauma Navigation System, which are 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 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/K254158
Methodology: https://510kreport.com/methodology