# K150301: NavSuite3 Kit

- Pathway: 510(k) (Special)
- Applicant: Stryker Leibinger GmbH & Co. KG - Navigation
- Decided: Jul 8, 2015 after 152 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: 2 generations back to K002732 (2000). 2 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130874: Stryker NAV3I Platform, Stryker Corporate (2013) Summary page 5.

## Most influential descendants
- 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
- K220593: Spine Guidance Software, Stryker Q Guidance System (2022), 10 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own

## Indications for use
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation 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 NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques. The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation 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 NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.

Source page: https://510kreport.com/device/K150301
Methodology: https://510kreport.com/methodology