# K230661: Zeta Cranial Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Zeta Surgical
- Decided: Sep 8, 2023 after 182 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: 5 generations back to K993239 (2000). 9 ancestors in all.
3 later devices descend 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)
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, 7D Surgical, Inc. (2019) Summary page 4.

## Most influential descendants
- K233903: Zeta Cranial Navigation System (ZNS131-US) (2024), 2 descendants of its own
- K242351: Zeta Cranial Navigation System (ZNS131-US) (2024), 1 descendant of its own
- 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 only indicated 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/K230661
Methodology: https://510kreport.com/methodology