# K060336: Navitrack System-OS Knee Universal, Model Pro-05002

- Pathway: 510(k) (Special)
- Applicant: Orthosoft, Inc.
- Decided: Apr 28, 2006 after 77 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (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.
91 later devices descend from it; 3 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021760: Navitrack System-Optical TKR CT-Less, Model 900.120, Orthosoft, Inc. (2002) Summary page 1.
- K043536: Navitrack System - S&N Image Free Knee, Orthosoft, Inc. (2005) Summary page 1.

## Most influential descendants
- K071714: Navitrack System - OS Unicondylar Knee Universal, Model#  Pro-06003 (2007), 79 descendants of its own
- 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

## 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.
- Oct 28, 2008 · Class II · Z-2076-2017: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erro
- Jun 20, 2008 · Class III · Z-2075-2017: ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

## Indications for use
The Navitrack® System - OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total 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/K060336
Methodology: https://510kreport.com/methodology