# K253856: Geniant Cranial (Navigated Neurosurgical Positioning Robot)

- Pathway: 510(k) (Traditional)
- Applicant: Koh Young Technology, Inc.
- Decided: Sep 10, 2026 after 281 days
- Product code: HAW (Neurological 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: 11 generations back to K002053 (2000). 30 ancestors in all.
No later device cites it as a predicate yet.
7 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241333: Geniant Cranial (Navigated Neurosurgical Positioning Robot), Koh Young Technology, Inc. (2025) Summary page 5.

## Indications for use
The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation. of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.

Source page: https://510kreport.com/device/K253856
Methodology: https://510kreport.com/methodology