# K253663: Zeta Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Zeta Surgical, Inc.
- Decided: May 1, 2026 after 162 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: 8 generations back to K993239 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242351: Zeta Cranial Navigation System (ZNS131-US), Zeta Surgical, Inc. (2024) Summary page 5.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 5.
- K162604: Cranial Reducing Tubes, Medtronic Navigation, Inc. (2016) Summary page 5.

## Indications for use
The Zeta 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. The Zeta Stylet is intended to be used in conjunction only with the Zeta Navigation System to provide stereotaxic guidance for the placement and operation of catheters, shunts or similar products, and anatomy registration during cranial procedures. The Zeta Bolt is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction only with the Zeta Navigation System using preoperative MR and/or CT imaging. These procedures include brain biopsies.

Source page: https://510kreport.com/device/K253663
Methodology: https://510kreport.com/methodology