# K213392: INLIANT Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Navigate Surgical Technologies, Inc.
- Decided: Feb 22, 2022 after 130 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.
No later device cites it as a predicate yet.
0 of 5 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.

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

Source page: https://510kreport.com/device/K213392
Methodology: https://510kreport.com/methodology