# K014256: Kolibri Igs Systems

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 19, 2002 after 205 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). 3 ancestors in all.
419 later devices descend from it; 7 cite it directly.
4 of 423 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000) Summary page 2.
- K003589: Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent, Brainlab AG (2001) Summary page 1.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 1.
- (no number) COMPASS Regulus Navigator: named in the summary without a submission number

## Most influential descendants
- K042721: Kolibri Spine (2005), 187 descendants of its own
- K052213: Navigation SW Hip 3.1 on CI (2005), 170 descendants of its own
- K053159: Vectorvision Spine (2006), 155 descendants of its own
- K060468: Vectorvision Hip (2006), 154 descendants of its own
- K031770: CI TKR/Ukr (2003), 134 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 Kolibit 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 fimited to: I . Tumor resections 2. Sku-,ullbase surgery 3. Cranial biopsies 4. Craniotomies/Cmniectornies; Example image guided ENT surgery procedures include, but are not limited to: 1. Transphenoidal procedures 2. Maxillary antrostomies 3. Ethmoidectomies, 4. SphenoidotomiesJsphenoid explorations, 5. Turbinate resections 6. Frontal sinusotomies 7. Intranasal procedures

Source page: https://510kreport.com/device/K014256
Methodology: https://510kreport.com/methodology