# K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Jun 12, 2000 after 52 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
751 later devices descend from it; 9 cite it directly.
6 of 752 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014256: Kolibri Igs Systems (2002), 419 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
- K042721: Kolibri Spine (2005), 187 descendants of its own

## Recalls of this device
- Jul 18, 2016 · Class II · Z-2317-2016: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
- Jul 18, 2016 · Class II · Z-2319-2016: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
- 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 1, 2006 · Not classified · Z-0718-06: Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Source page: https://510kreport.com/device/K001284
Methodology: https://510kreport.com/methodology