# 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

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Nov 12, 2021 after 224 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: 11 generations back to K862807 (1986). 88 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 91 devices in its family (counting itself) has 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.

## Most influential descendants
- 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
- 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
The Cirq Robotic Alignment Module is an intraoperative robotic positioning system and an accessory to compatible Brainlab IGS Cranial software applications. Using spatial information from an image guided navigation system, the Cirq Robotic Alignment Module enables the surgeon to align and hold surgical instruments according to pre-planned trajectories. The Cirq Robotic Alignment Module is indicated for stereotactic biopsies of intracranial lesions.

Source page: https://510kreport.com/device/K210989
Methodology: https://510kreport.com/methodology