# K022414: Stealthstation System Three Dimensional C-Arm Interface

- Pathway: 510(k) (Special)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Aug 14, 2002 after 21 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
No predicates in its family tree.
304 later devices descend from it; 3 cite it directly.
2 of 305 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
- 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
- K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own

## Indications for use
The StealthStation& System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The SteaIthStationCC 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. Example procedures include, but are not limited to: Cranial Procedures: Spinal Procedures: Cranial Biopsies Spinal Implant Procedures, such as Pedicle Screw Placement Tumor Resections Craniotomies/ Craniectomies Orthopedic Procedures: Skull Base procedures Total Knee Arthroplasty (Primary and Revision) Thalarnotomies/Pallidotomies Unicompahental Knee Arthroplasty Pituitary Tumor Removal CSF Leak Repair ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital 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

Source page: https://510kreport.com/device/K022414
Methodology: https://510kreport.com/methodology