# K192579: X-Guide Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Nav Technologies, LLC
- Decided: Feb 3, 2020 after 137 days
- Product code: PLV (Dental Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983831 (1999). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150222: X-Guide Surgical Navigation System, X-Nav Technologies, LLC (2015) Summary page 5.

## Most influential descendants
- K211701: X-Guide® Surgical Navigation System (2022), 2 descendants of its own
- K232148: X-Guide Surgical Navigation System (2024), 1 descendant of its own
- K253954: X-Guide Surgical Navigation System (2026), 0 descendants of its own

## Indications for use
The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who require dental implants as part of their treatment plan.

Source page: https://510kreport.com/device/K192579
Methodology: https://510kreport.com/methodology