# K241333: Geniant Cranial (Navigated Neurosurgical Positioning Robot)

- Pathway: 510(k) (Traditional)
- Applicant: Koh Young Technology, Inc.
- Decided: Jan 17, 2025 after 252 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: 10 generations back to K002053 (2000). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
7 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200511: ROSA ONE Brain application, Medtech S.A (2020) Summary page 5.
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software, Medtronic Navigation, Inc. (2017) Summary page 5.

## Most influential descendants
- K253856: Geniant Cranial (Navigated Neurosurgical Positioning Robot) (2026), 0 descendants of its own

## 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/K241333
Methodology: https://510kreport.com/methodology