# K242890: SPINEART Navigation Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Mar 7, 2025 after 165 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: 19 generations back to K040583 (2004). 196 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210472: SPINEART Navigation Instrument System, Spineart (2021) Summary page 5.
- K231886: SURGIVISIO Device, Ecential Robotics (2023) Summary page 5.

## Most influential descendants
- K242933: SPINEART Navigation Instrument System (2025), 2 descendants of its own
- K254158: SPINEART Navigation Instrument System (2026), 1 descendant of its own
- K261205: SPINEART Navigation Instrument System (2026), 0 descendants of its own

## Indications for use
The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TIL screws during thoracolumbar 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 eCential Op.n PERLA® TL Nay System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The guidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nay Software and based on intraoperative 3D images provided by a compatible imaging system.

Source page: https://510kreport.com/device/K242890
Methodology: https://510kreport.com/methodology