# K071714: Navitrack System - OS Unicondylar Knee Universal, Model#  Pro-06003

- Pathway: 510(k) (Special)
- Applicant: Orthosoft, Inc.
- Decided: Jul 20, 2007 after 28 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002053 (2000). 10 ancestors in all.
79 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060336: Navitrack System-OS Knee Universal, Model Pro-05002, Orthosoft, Inc. (2006) Summary page 1.
- K062146: Uni Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.

## Most influential descendants
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), 76 descendants of its own
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System (2012), 46 descendants of its own
- K143752: Total Knee Application (TKA) (2015), 44 descendants of its own
- K170581: Mako Total Knee Application (2017), 38 descendants of its own

## Recalls of this device
- Nov 2, 2009 · Not classified · Z-0558-2010: The power cord female receptacle is not recessed sufficiently and may present a shock hazard.
- Aug 19, 2008 · Not classified · Z-0985-2009: Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial 

## Indications for use
The Navitrack System - OS Unicondylar Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of unicondylar knee replacement components intra-operatively. It is a computer controlled image-guidance system equipped with a three- dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Source page: https://510kreport.com/device/K071714
Methodology: https://510kreport.com/methodology