# K232148: X-Guide Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Nav Technologies, LLC
- Decided: Feb 21, 2024 after 217 days
- Product code: QRY (Dental Navigation System)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K983831 (1999). 6 ancestors in all.
1 later device descends 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)
- K211701: X-Guide® Surgical Navigation System, X-Nav Technologies, LLC (2022) Summary page 5.

## Most influential descendants
- K253954: X-Guide Surgical Navigation System (2026), 0 descendants of its own

## Recalls of this device
- Mar 4, 2024 · Class II · Z-1392-2024: The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
- Mar 4, 2024 · Class II · Z-1393-2024: The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

## Indications for use
The X-Guide® 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 and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access 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 need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.

Source page: https://510kreport.com/device/K232148
Methodology: https://510kreport.com/methodology