# K042391: Kolibri Image Guided Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Oct 19, 2004 after 47 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.
72 later devices descend from it; 3 cite it directly.
1 of 78 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014256: Kolibri Igs Systems, Brainlab AG (2002) Summary page 1.
- K022126: Catheter Introducer for the Stealthstation System, Medtronic Surgical Navigation Technologies (2003) Summary page 2.

## Most influential descendants
- 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
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own

## Indications for use
The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer 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 long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy. Example image guided cranial surgery procedures include but are not limited to: 1. Tumor resections 2. Skull base surgery 3. Cranial biopsies 4. Craniotomies/Craniectomies 5. Pediatric Catheter Shunt Placement 6. General Catheter Shunt Placement Example image guided ENT surgery procedures include but are not limited to: 1. Transphenoidal procedures 2. Maxillary antrostomies 3. Ethmoidectomies, 4. Sphenoidotomies./sphenoid explorations, 5. Turbinate resections 6. Frontal sinusotomies 7. Intranasal procedures

Source page: https://510kreport.com/device/K042391
Methodology: https://510kreport.com/methodology