# K030827: Navitrack System: Total Hip Replacement CT-Free Cup, Model 900.204

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft, Inc.
- Decided: May 23, 2003 after 70 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: 2 generations back to K002053 (2000). 3 ancestors in all.
46 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022364: Navitrack System Total Hip Replacement,Model 900.200, Orthosoft, Inc. (2003)

## Most influential descendants
- 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
- K153237: OrthAlign Plus System (2016), 18 descendants of its own
- K162962: OrthAlign Plus System (2017), 15 descendants of its own

## Recalls of this device
- Aug 6, 2007 · Not classified · Z-2445-2008: Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infe

## Indications for use
The NavitrackTMSystem - Total Hip Replacement CT-Free Cup 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/K030827
Methodology: https://510kreport.com/methodology