# K242914: Op.n (TM) Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Ecential Robotics
- Decided: Mar 7, 2025 after 164 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K261113: Op.n™ Spine Navigation and Robotic Guidance (2026), 1 descendant of its own
- K261205: SPINEART Navigation Instrument System (2026), 0 descendants of its own

## Indications for use
Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery. The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intra-operative 3D images provided by a compatible imaging system. The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region. Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.

Source page: https://510kreport.com/device/K242914
Methodology: https://510kreport.com/methodology