# K223864: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 9, 2023 after 260 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: 12 generations back to K862807 (1986). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.
- K210989: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System, Brainlab AG (2021) Summary page 4.
- 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, Brainlab AG (2020) Summary page 4.

## Most influential descendants
- 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 (2025), 0 descendants of its own

## Indications for use
Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures. The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEEG) electrodes.

Source page: https://510kreport.com/device/K223864
Methodology: https://510kreport.com/methodology