# K250255: xvision Spine system

- Pathway: 510(k) (Special)
- Applicant: Augmedics, Ltd.
- Decided: Mar 13, 2025 after 44 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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 K050438 (2005). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241481: xvision Spine System, Augmedics, Ltd. (2024) Summary page 5.

## Most influential descendants
- K251639: xvision Spine system (2025), 1 descendant of its own
- K261854: xvision Spine system (2026), 0 descendants of its own

## Indications for use
The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to a patient’s fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures: - Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - Posterior Screw Placement in C3-C7 vertebrae - Iliosacral Screw Placement - Angular procedures requiring access to the disc space - Lateral trajectories required to access the Sacro-Iliac joint The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

Source page: https://510kreport.com/device/K250255
Methodology: https://510kreport.com/methodology