# K043536: Navitrack System - S&N Image Free Knee

- Pathway: 510(k) (Special)
- Applicant: Orthosoft, Inc.
- Decided: Jan 14, 2005 after 23 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: 2 generations back to K002053 (2000). 3 ancestors in all.
342 later devices descend from it; 5 cite it directly.
5 of 346 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.

## Most influential descendants
- K060556: Brigit Surgical Device (2006), 128 descendants of its own
- K092239: Rosa Surgical Device, Model Rosa 1.1 (2009), 127 descendants of its own
- K101791: Rosa Surgical Device (2010), 126 descendants of its own
- K061362: Pigalileo Total Knee Replacement (TKR) System (2006), 126 descendants of its own
- K151511: ROSA Spine (2016), 109 descendants of its own

## Indications for use
The Navitrack® System - S&N Image Free Knee 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/K043536
Methodology: https://510kreport.com/methodology