# K261113: Op.n™ Spine Navigation and Robotic Guidance

- Pathway: 510(k) (Traditional)
- Applicant: Ecential Robotics
- Decided: Jul 22, 2026 after 110 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). 706 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 708 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242914: Op.n (TM) Navigation, Ecential Robotics (2025) Summary page 6.
- K233228: Spine Navigation and Robotic-Assistance Device, Ecential Robotics (2024) Summary page 6.

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

## Indications for use
Op.n™ Spine Navigation and Robotic Guidance, when used with an Op.n™ Spine Navigation and Robotic Guidance Software, is intended for the spatial positioning and orientation of compatible surgical instruments to be used by surgeons during general spinal surgery, in Instruments navigation mode and/ or robotic guidance mode. The instrument navigation mode and the robotic guidance mode are based on patient 3D image data, on which the surgeon may perform an intraoperative surgical planning. Op.n™ Spine Navigation and Robotic Guidance Software is a surgical navigation software. It is intended to provide guidance for the positioning of compatible surgical instruments to be used by surgeons. The software is indicated for the placement of spinal bone screws, in instrument navigation mode and/or robotic guidance mode, in vertebrae with a posterior approach in the thoracolumbar and sacral regions.

Source page: https://510kreport.com/device/K261113
Methodology: https://510kreport.com/methodology