# K062358: Modification to Vectorvision Trauma

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Jan 17, 2007 after 156 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
Longest line of descent: 2 generations back to K983831 (1999). 3 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012448: Vectorvision Trauma, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K110204: Brainlab Trauma (2011), 27 descendants of its own
- K130887: S4C Navigation Instruments (2013), 13 descendants of its own
- K181890: Brainlab Compatible K2M Navigation Instruments (2018), 11 descendants of its own
- K192911: Brainlab Compatible K2M Navigation Instruments (2019), 9 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own

## Indications for use
BrainLAB VectorVision Trauma is intended to be a pre- and 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 a patient's pre- or intraoperative image data being processed by a 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: Spinal procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or plating or screwing or external fixation procedures in the tubular bones.

Source page: https://510kreport.com/device/K062358
Methodology: https://510kreport.com/methodology