# K150222: X-Guide Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Nav Technologies, LLC
- Decided: Oct 8, 2015 after 251 days
- Product code: PLV (Dental Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983831 (1999). 3 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023424: Igi-System, Denx Advanced Dental Systems (2003) Summary page 4.

## Most influential descendants
- 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
- K222049: Yomi Robotic System (2022), 4 descendants of its own

## Recalls of this device
- Feb 23, 2016 · Class II · Z-1391-2016: The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan 

## 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 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/K150222
Methodology: https://510kreport.com/methodology