# K031156: Navitrack System-Fluorospine, Model 900.005

- Pathway: 510(k) (Special)
- Applicant: Orthosoft, Inc.
- Decided: May 9, 2003 after 28 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). 1 ancestor in all.
36 later devices descend from it; 1 cites it directly.
0 of 38 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.

## Most influential descendants
- K033413: Spineassist Device (2004), 35 descendants of its own
- K051676: Spineassist Device with Additional Accessories (2005), 34 descendants of its own
- K063607: Spineassist System (2007), 33 descendants of its own
- K073467: Spineassist System (2008), 32 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own

## Indications for use
The NavitrackTMSystem - FluoroSpine is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopaedic surgery, such as operations performed within spinal structures.

Source page: https://510kreport.com/device/K031156
Methodology: https://510kreport.com/methodology