# K233228: Spine Navigation and Robotic-Assistance Device

- Pathway: 510(k) (Traditional)
- Applicant: Ecential Robotics
- Decided: Jun 14, 2024 after 260 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 704 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 707 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231886: SURGIVISIO Device, Ecential Robotics (2023) Summary page 4.
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 4.

## 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

## Recalls of this device
- Jul 23, 2026 · Class II · Z-3088-2026: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

## Indications for use
Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position. Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a three-dimensional image volume (3D CT or CBCT image), on which the surgeon may perform the Intraoperative Surgical Planning. Spine Navigation and Robotic-Assistance Device is indicated to provide guidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.

Source page: https://510kreport.com/device/K233228
Methodology: https://510kreport.com/methodology