# K022364: Navitrack System Total Hip Replacement,Model 900.200

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft, Inc.
- Decided: Feb 4, 2003 after 197 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 K002053 (2000). 2 ancestors in all.
82 later devices descend from it; 5 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002053: Navitrak System-Optical Option, Model 900.004, Orthosoft, Inc. (2000) Summary page 1.
- K010602: Vectorvision Hip, Brainlab AG (2001)

## Most influential descendants
- K030827: Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204 (2003), 46 descendants of its own
- K041369: Navitrack System - S&N Image Free Hip, Model Pro-03017 (2004), 41 descendants of its own
- K130387: Orthoalign Plus System (2013), 31 descendants of its own
- K140331: Orthalign Plus System (2014), 29 descendants of its own
- K160284: JointPoint (2016), 21 descendants of its own

## Indications for use
The NavitrackTMSystem - Total Hip Replacement 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 that integrates a three-dimensional tracking sub-system and image-processing software. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images.

Source page: https://510kreport.com/device/K022364
Methodology: https://510kreport.com/methodology