# K023424: Igi-System

- Pathway: 510(k) (Traditional)
- Applicant: Denx Advanced Dental Systems
- Decided: May 9, 2003 after 210 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: 1 generation back to K983831 (1999). 2 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 2.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 2.

## Most influential descendants
- K150222: X-Guide Surgical Navigation System (2015), 26 descendants of its own
- K161399: Neocis Guidance System (2016), 15 descendants of its own
- K202264: Neocis Guidance System (NGS) with Yomi Plan v2.0 (2020), 7 descendants of its own
- K210711: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (2021), 5 descendants of its own
- K173402: Neocis Guidance System (NGS) with Chairside Splint (2018), 5 descendants of its own

## Indications for use
The IGI-System.lbi, Image-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planpmg4.p dental implantation procedure.

Source page: https://510kreport.com/device/K023424
Methodology: https://510kreport.com/methodology