# K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017

- Pathway: 510(k) (Special)
- Applicant: Orthosoft, Inc.
- Decided: Jun 22, 2004 after 29 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002053 (2000). 4 ancestors in all.
41 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030827: Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204, Orthosoft, Inc. (2003) Summary page 1.

## Most influential descendants
- K130387: Orthoalign Plus System (2013), 31 descendants of its own
- K140331: Orthalign Plus System (2014), 29 descendants of its own
- K153237: OrthAlign Plus System (2016), 18 descendants of its own
- K162962: OrthAlign Plus System (2017), 15 descendants of its own
- K171780: OrthAlign Plus System (2017), 12 descendants of its own

## Recalls of this device
- Apr 27, 2006 · Not classified · Z-2444-2008: The three-point array may break during use, resulting in surgical delay and an increased risk of infection.

## Indications for use
The Navitrack TM System - S&N Image Free Hip is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

Source page: https://510kreport.com/device/K041369
Methodology: https://510kreport.com/methodology