# K021760: Navitrack System-Optical TKR CT-Less, Model 900.120

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft, Inc.
- Decided: Aug 27, 2002 after 90 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.
363 later devices descend from it; 4 cite it directly.
5 of 366 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.
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 1.

## Most influential descendants
- K043536: Navitrack System - S&N Image Free Knee (2005), 342 descendants of its own
- K031196: Surgetics Ortho Kneelogics Navigation System (2005), 149 descendants of its own
- K060282: Total Knee Surgetics Navigation System (2006), 147 descendants of its own
- K060556: Brigit Surgical Device (2006), 128 descendants of its own
- K092239: Rosa Surgical Device, Model Rosa 1.1 (2009), 127 descendants of its own

## Indications for use
The NavitrackTMSystem - Optical TKR CT-Less 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/K021760
Methodology: https://510kreport.com/methodology