# K082060: Cranial Image Guided Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 8, 2009 after 291 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: 3 generations back to K983831 (1999). 7 ancestors in all.
16 later devices descend from it; 5 cite it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042391: Kolibri Image Guided Surgery System, Brainlab AG (2004) Summary page 1.
- K023651: Vectorvision Cranial/Ent, Brainlab AG (2004) Summary page 1.

## Most influential descendants
- K092467: Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited (2010), 10 descendants of its own
- K192703: Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update (2020), 3 descendants of its own
- K171661: Scopis Extended Instrument Set EM (2017), 3 descendants of its own
- K100038: Disposable Reflective Marker Spheres (2010), 2 descendants of its own
- K223864: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (2023), 1 descendant of its own

## Indications for use
The BrainLAB Cranial IGS System is intended to be an intra-operative 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 patient image data being processed by the IGS 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, CTA, X-Ray, MR, MRA and ultrasound based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies Pediatric Catheter Shunt Placement General Catheter Shunt Placement Thalamotomies/ Palliodotomies ENT Procedures: Transphenoidal procedures Maximillary antrostomies Ethmoidectomies Spheno-idotomies/ sphenoid explorations Turbinate resections Frontal sinusotomies Intranasal procedures

Source page: https://510kreport.com/device/K082060
Methodology: https://510kreport.com/methodology