# K221028: SURGIVISIO Device

- Pathway: 510(k) (Traditional)
- Applicant: Ecential Robotics
- Decided: Jul 6, 2022 after 90 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: 8 generations back to K002053 (2000). 30 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap  3D 3.0-Enable, Spinemap  3D 3.0-Sales D, Stryker Corporate (2014) Summary page 4.
- K182848: ROSA ONE Spine application, Medtech S.A (2019) Summary page 4.

## Most influential descendants
- K231886: SURGIVISIO Device (2023), 6 descendants of its own
- K242890: SPINEART Navigation Instrument System (2025), 3 descendants of its own
- K242933: SPINEART Navigation Instrument System (2025), 2 descendants of its own
- K233228: Spine Navigation and Robotic-Assistance Device (2024), 2 descendants of its own
- K261113: Op.n™ Spine Navigation and Robotic Guidance (2026), 1 descendant of its own

## Indications for use
The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized The SURGIVISIO Device through its freehand navigation feature is intended as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach. The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPXlInstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.

Source page: https://510kreport.com/device/K221028
Methodology: https://510kreport.com/methodology