# K242351: Zeta Cranial Navigation System (ZNS131-US)

- Pathway: 510(k) (Special)
- Applicant: Zeta Surgical, Inc.
- Decided: Oct 4, 2024 after 57 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: 7 generations back to K993239 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233903: Zeta Cranial Navigation System (ZNS131-US), Zeta Surgical, Inc. (2024) Summary page 5.

## Most influential descendants
- K253663: Zeta Navigation System (2026), 0 descendants of its own

## Indications for use
The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites.

Source page: https://510kreport.com/device/K242351
Methodology: https://510kreport.com/methodology