# K023651: Vectorvision Cranial/Ent

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Feb 17, 2004 after 475 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983831 (1999). 2 ancestors in all.
148 later devices descend from it; 5 cite it directly.
6 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 1.
- K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent, Brainlab AG (2001) Summary page 1.

## Most influential descendants
- K101791: Rosa Surgical Device (2010), 126 descendants of its own
- K151511: ROSA Spine (2016), 109 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K182964: ROSA Knee System (2019), 29 descendants of its own

## Recalls of this device
- Nov 12, 2007 · Not classified · Z-2209-2008: Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to d

## Indications for use
VectorVision Cranial/ENT is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on patient image data being processed by the VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies / Sphenoid explorations, Turbinate resections and Frontal sinusotomies

Source page: https://510kreport.com/device/K023651
Methodology: https://510kreport.com/methodology