# K042721: Kolibri Spine

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 19, 2005 after 200 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). 5 ancestors in all.
187 later devices descend from it; 4 cite it directly.
3 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010968: Vectorvision CT/Fluoro, Brainlab AG (2001) Summary page 1.
- K014256: Kolibri Igs Systems, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- K053159: Vectorvision Spine (2006), 155 descendants of its own
- K070106: VV Fluoro 3D (2007), 119 descendants of its own
- K062086: Navivision (2006), 77 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

## Indications for use
BrainLAB's Kolibri spine 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 a patient's preoperative image data being processed by a Kolibri 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: Spinal implant procedures such as pedicle screw placement 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/K042721
Methodology: https://510kreport.com/methodology