# K241327: Navient Image Guide Navigation System (955-NC-NC), Cranial

- Pathway: 510(k) (Traditional)
- Applicant: Claronav
- Decided: Feb 5, 2025 after 271 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 K050438 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
4 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212397: StealthStation S8 Cranial v2.0, Medtronic Navigation (2021) Summary page 5.

## Indications for use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Navient system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT, MR based model of the anatomy. Indications: Example procedures include but are not limited to: Cranial Procedures: • Tumor resections • Cranial biopsies • Craniotomies • Pediatric Catheter Shunt Placement • General Catheter Shunt Placement

Source page: https://510kreport.com/device/K241327
Methodology: https://510kreport.com/methodology