# K202320: CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Dec 23, 2020 after 128 days
- Product code: OLO (Orthopedic 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: 7 generations back to K983831 (1999). 12 ancestors in all.
9 later devices descend from it; 3 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183605: Spine & Trauma Navigation, Brainlab AG (2019) Summary page 4.

## Most influential descendants
- K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System (2022), 6 descendants of its own
- K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (2024), 1 descendant of its own
- K262257: Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (2026), 0 descendants of its own
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (2026), 0 descendants of its own
- K252755: POINT Kinguide Agile Robotic Arm Surgical Stereotactic System (2026), 0 descendants of its own

## Indications for use
For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.

Source page: https://510kreport.com/device/K202320
Methodology: https://510kreport.com/methodology