# K211254: ARAI Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgalign Spine Technologies
- Decided: Jan 14, 2022 after 263 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: 4 generations back to K050438 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 4.

## Most influential descendants
- K231611: HOLO Portal™ Surgical Guidance System (2023), 0 descendants of its own

## Indications for use
The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

Source page: https://510kreport.com/device/K211254
Methodology: https://510kreport.com/methodology