# K030106: Stealthstation System Advanced Contour Registration Software Module

- Pathway: 510(k) (Special)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Feb 12, 2003 after 30 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.
290 later devices descend from it; 3 cite it directly.
2 of 291 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 indications for use for the StealthStationB System indications for use are identical to the StealthStationB System indications for use. The indications for use are as follows: The StealthStationB System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStationB 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 Tumor Resections Screw Placement Craniotomies/ Craniectomies Skull Base procedures Orthopedic Procedures: Thalamotomies/Pallidotoniies Total Knee Arthroplasty (Primary and Revision) Pituitary Tumor Removal Uiiicompartniental Knee Arthroplasty CSF Leak Repair Minimally Invasive Orthopedic Procedures Pediatric Catheter Shunt Placement Total Hip Replacement (Primary and Revision) General Catheter Shunt Placement Tumor Resection and Bone/Joint Reconstruction Femoral Revision ENT Procedures: Placement of Iliosacral Screws Transphenoidal Procedures Stabilization and Repair of Pelvic Fractures Intranasal Procedures (Including but not Limited to Acetabular Orbital Nerve Decompression Procedures Fractures) 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/K030106
Methodology: https://510kreport.com/methodology