# K022126: Catheter Introducer for the Stealthstation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Surgical Navigation Technologies
- Decided: Jan 3, 2003 after 186 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.
463 later devices descend from it; 5 cite it directly.
8 of 464 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
- (no number) Radionics Optical Tracking 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
- K033223: Zimmer Ortho Guidance Systems- Hip Instruments (2004), 133 descendants of its own
- K033011: Zimmer Ortho Guidance Systems- Knee Instruments (2004), 133 descendants of its own

## Indications for use
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 Screw Placement Tumor Resections Craniotomies/ Craniectomies ENT Procedures: Skull Base procedures Transphenoidal Procedures Thalamotomies/Pallidotomies Intranasal Procedures Pituitary Tumor Removal Orbital Nerve Decompression Procedures CSF Leak Repair Optic Nerve Decompression Procedures Pediatric Catheter Shunt Placement Polyposis Procedures General Catheter Shunt Placement Endoscopic Dacryocystorhinostomy Encephalocele Procedures Orthopedic Procedures: Sinus procedures, such as Maxillary Antrostomies, Total Knee Arthroplasty (Primary and Revision) Ethmoidectomies, Sphenoidotomies/Sphenoid Unicompartmental Knee Arthroplasty Explorations, Turbinate Resections,and Frontal Minimally Invasive Orthopedic Procedures Sinusotomies Pediatric Orthopedics Total Hip Replacement (Primaiy and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

Source page: https://510kreport.com/device/K022126
Methodology: https://510kreport.com/methodology