# K243698: Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jan 28, 2025 after 60 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: 13 generations back to K862807 (1986). 102 ancestors in all.
No later device cites it as a predicate yet.
3 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System, Medtronic Navigation, Inc. (2019) Summary page 5.
- K223864: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial, Brainlab AG (2023) Summary page 5.

## Indications for use
Alignment System Cranial is intended to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures. The indications for use are biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes and placement of anchor bolts for laser interstitial thermal therapy (LITT).

Source page: https://510kreport.com/device/K243698
Methodology: https://510kreport.com/methodology