# K261205: SPINEART Navigation Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Jul 29, 2026 after 107 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). 727 ancestors in all.
No later device cites it as a predicate yet.
4 of 728 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.
- K241644: SPINEART Navigation Instrument System, Spineart SA (2024) Summary page 5.
- K261113: Op.n™ Spine Navigation and Robotic Guidance, Ecential Robotics (2026). Cleared while this submission was under review Summary page 5.
- K242890: SPINEART Navigation Instrument System, Spineart SA (2025) Summary page 6.
- K254158: SPINEART Navigation Instrument System, Spineart SA (2026) Summary page 6.

## Indications for use
The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL 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 eCential Op.n PERLA® TL Nav or with Perla by Spineart device. It is indicated for population with medical conditions requiring the placement of thoracolumbar 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 Nav Software or with Perla by Spineart software and based on intra-operative 3D images provided by a compatible imaging system. eCential Op.n PERLA® TL Nav device is intended to be used for thoracolumbar vertebrae surgery. eCential Perla by Spineart device is intended to be used for thoracolumbar + S1 vertebrae surgery. The SPINEART Robotic reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Robotic reusable instruments are specifically designed for use with eCential Perla by Spineart device. It is indicated for population with medical conditions requiring the placement of thoracolumbar spinal screws and for which the use of stereotactic surgery with robotic arm guidance, 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 Perla by Spineart software, followed by related robotic arm positioning and instrument guiding, and checked on intra-operative 3D images provided by a compatible imaging system.

Source page: https://510kreport.com/device/K261205
Methodology: https://510kreport.com/methodology