# K242569: Mixed Reality Spine Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 16, 2025 after 261 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: 9 generations back to K983831 (1999). 33 ancestors in all.
No later device cites it as a predicate yet.
3 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System, Brainlab AG (2022) Summary page 5.

## Indications for use
Mixed Reality Spine Navigation is an accessory to the Spine & Trauma Navigation Medical Device. The software is intended to display 2D navigation screens as well as a floating 3D virtual representation and stereotaxic information of tracked instruments on a virtual display using a Mixed Reality headset. 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/K242569
Methodology: https://510kreport.com/methodology