# K243623: SpineAR SNAP (SyncAR Spine)

- Pathway: 510(k) (Special)
- Applicant: Surgical Theater, Inc.
- Decided: Dec 24, 2024 after 29 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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: 6 generations back to K050438 (2005). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213034: SpineAR SNAP, Surgical Theater, Inc. (2022) Summary page 5.

## Most influential descendants
- K252054: SpineAR SNAP (SyncAR Spine) (2025), 0 descendants of its own

## Recalls of this device
- Sep 16, 2025 · Class II · Z-0324-2026: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer

## Indications for use
SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intra-operative surgical planning and visualization on-screen and in an augmented environment using the HoloLens2 and Magic Leap 1 AR headset displays with validated navigation systems as identified in the device labeling. SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. SpineAR is intended for use in spinal implant procedures, such as Pedicle Screw Placement, in the lumbar and thoracic regions with the Magic Leap 1 and HoloLens2 AR headsets. The virtual 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/K243623
Methodology: https://510kreport.com/methodology