# K050438: Stealthstation System Update

- Pathway: 510(k) (Special)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Jun 2, 2005 after 100 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
944 later devices descend from it; 23 cite it directly.
14 of 945 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) StealthStation System: named in the summary without a submission number

## Most influential descendants
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), 246 descendants of its own
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials (2015), 242 descendants of its own

## Recalls of this device
- May 10, 2017 · Class II · Z-2746-2017: Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate
- Jul 18, 2016 · Class II · Z-2318-2016: 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-2313-2016: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
- Sep 14, 2015 · Class II · Z-2824-2015: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
- Nov 13, 2012 · Class II · Z-0441-2013: Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation System due to a defect related to the internal threading for component set up.
- Jun 2, 2011 · Not classified · Z-2781-2011: Software allows incorrect patient or patient history to be displayed.
- Dec 22, 2010 · Not classified · Z-1558-2011: Position Sensor Unit may generate tracking errors or may stop tracking immediately.
- Dec 15, 2010 · Not classified · Z-1042-2011: Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
- Nov 5, 2010 · Not classified · Z-0715-2011: Electronic surgical navigation aid may lose tracking ability or stop working.
- Sep 24, 2010 · Not classified · Z-0145-2011: Drill guide handle may detach unintentionally during use.
- Jun 14, 2010 · Not classified · Z-2029-2010: Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock.

## Indications for use
This submission does not change the indications for use for the StealthStation System. 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, fluoroscopy images, or digitized landmarks of the anatomy. For the optical-based and EM-based system, example procedures include, but are not limited to: Cranial Procedures: Cranial Biopsies Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement Spinal Procedures Spinal Implant Procedures, such as Pedicle Screw Placement ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations. Turbinate Resections, and Frontal Sinusotomies Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Additional example procedures for the optical-based system include, but are not limited to: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Iliosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not limited to Acetabular Fractures)

Source page: https://510kreport.com/device/K050438
Methodology: https://510kreport.com/methodology