# K012448: Vectorvision Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Mar 14, 2002 after 225 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: 1 generation back to K983831 (1999). 2 ancestors in all.
251 later devices descend from it; 6 cite it directly.
0 of 254 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
- K090420: Smith & Nephew Pigalileo Screw Targeting System V 1.0 (2009), 78 descendants of its own
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 (2009), 77 descendants of its own
- K100107: Smith & Nephew Sureshot Distal Targeting System V2.0 (2010), 75 descendants of its own
- K060727: Vectorvision Hip (2006), 71 descendants of its own
- K083483: Brainlab Hip Unlimited, CI Hip Unlimited (2009), 70 descendants of its own

## Indications for use
BrainLAB VectotVision 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 VectorVisian 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, fluaroscopic, 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 ar external fixation procedures in the tubular bones.

Source page: https://510kreport.com/device/K012448
Methodology: https://510kreport.com/methodology