# K990214: Fluoronav Module for the Stealthstation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Apr 22, 1999 after 90 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
450 later devices descend from it; 6 cite it directly.
4 of 451 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) original StealthStation® System: named in the summary without a submission number

## Most influential descendants
- K994270: Instatrak 3000 System with Fluorotrak Module, Model IT3000 (2000), 294 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own
- K013025: Modification to Flourolab Plus (2001), 151 descendants of its own

## Recalls of this device
- Apr 24, 2014 · Class II · Z-1581-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1600-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1582-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1587-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1601-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1591-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1584-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1578-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1580-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1595-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1594-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1593-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1596-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1590-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1589-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1598-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1592-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1585-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1579-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1602-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1583-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1599-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1588-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1597-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1586-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Feb 6, 2012 · Not classified · Z-1189-2012: When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra.
- Feb 6, 2012 · Not classified · Z-1190-2012: When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra.
- Jan 20, 2011 · Not classified · Z-0001-2012: Distal end of tactile probe may break off during use.
- Jan 20, 2011 · Not classified · Z-0002-2012: Distal end of tactile probe may break off during use.

## Indications for use
The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.

Source page: https://510kreport.com/device/K990214
Methodology: https://510kreport.com/methodology