# K053159: Vectorvision Spine

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 6, 2006 after 204 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: 3 generations back to K983831 (1999). 6 ancestors in all.
155 later devices descend from it; 3 cite it directly.
1 of 162 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010968: Vectorvision CT/Fluoro, Brainlab AG (2001) Summary page 1.
- K042721: Kolibri Spine, Brainlab AG (2005) Summary page 1.

## Most influential descendants
- K070106: VV Fluoro 3D (2007), 119 descendants of its own
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90) (2008), 53 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K100931: Mylabtwice, Model 6200 (2010), 46 descendants of its own
- K083310: Spine & Trauma Ict (2009), 40 descendants of its own

## Recalls of this device
- Nov 15, 2013 · Class II · Z-0967-2014: Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necess

## Indications for use
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is 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, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray or MR-based model of the anatomy. Example procedures include but are not limited to: * Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique) * Spinal implant procedures such as * Pedicle screw placement * Anterior plating * Kyphoplasty and vertebroplasty procedures * Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes * Thoracic spine surgery * Tumor surgery on the spinal column and adjacent soft tissue * Placement of acetabular and SI screws on the pelvis

Source page: https://510kreport.com/device/K053159
Methodology: https://510kreport.com/methodology