# K983831: VECTORVISION2

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 19, 1999 after 201 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.
611 later devices descend from it; 12 cite it directly.
9 of 612 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K014256: Kolibri Igs Systems (2002), 419 descendants of its own
- K012448: Vectorvision Trauma (2002), 251 descendants of its own
- K042721: Kolibri Spine (2005), 187 descendants of its own
- K052213: Navigation SW Hip 3.1 on CI (2005), 170 descendants of its own
- K053159: Vectorvision Spine (2006), 155 descendants of its own

## Indications for use
BrainLAB VectorVision Spider is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s images data being processed by a VectorVision Spider workstation. The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a CT, MR or X-ray based model of the anatomy.

Source page: https://510kreport.com/device/K983831
Methodology: https://510kreport.com/methodology