# K210700: NaviNetics D1 Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: Navinetics, Inc.
- Decided: Jun 17, 2021 after 100 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: 4 generations back to K031999 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190887: Leksell Vantage Stereotactic System, Elekta Instrument AB (2019) Summary page 4.

## Most influential descendants
- K231392: NaviNetics Reusable Stereotactic System (NN1000) (2023), 0 descendants of its own

## Indications for use
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Source page: https://510kreport.com/device/K210700
Methodology: https://510kreport.com/methodology