# K022239: Surgetics Entact Endonasal Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Praxim
- Decided: Aug 23, 2002 after 43 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K000310 (2000). 1 ancestor in all.
35 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000310: Voyager 6.0 Software Option, Philips Medical Systems (Cleveland), Inc. (2000)

## Most influential descendants
- K063408: Ctlogics Navigations Systems (2007), 34 descendants of its own
- K081232: Total Knee Surgetics Navigation System with Praxiteles (2008), 18 descendants of its own
- K090953: Total Knee Surgetics Navigation System with Iblock (2010), 17 descendants of its own
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2017), 15 descendants of its own
- K173372: ExactechGPS Total Shoulder Application (2017), 14 descendants of its own

## Indications for use
The Surgetics ENTact Endonasal Navigation System is intended for use as an aid to the surgeon for precisely locating anatomical structures either during open or percutaneous ENT/endonasal or sinus procedures.

Source page: https://510kreport.com/device/K022239
Methodology: https://510kreport.com/methodology