# K130874: Stryker NAV3I Platform

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporate
- Decided: Sep 27, 2013 after 182 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K002732 (2000). 1 ancestor in all.
22 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002732: Stryker  Navigation System - Ent Module, Stryker Corp. (2000) Summary page 2.

## Most influential descendants
- K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees) (2014), 20 descendants of its own
- K150301: NavSuite3 Kit (2015), 18 descendants of its own
- K153240: Styrker OrthoMap Express Knee System (2016), 17 descendants of its own
- K162341: Stryker OrthoMap Precision Knee system (2016), 16 descendants of its own
- K172034: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap (2017), 12 descendants of its own

## Indications for use
The NAV3I Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Source page: https://510kreport.com/device/K130874
Methodology: https://510kreport.com/methodology