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Cirq Arm System (2.0); Alignment System Spine

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222966

by Brainlab AG

Identifiers

510(k) Number
K222966 FDA 510(k)
FDA Product Code
OLO FDA 510(k)
Models / Variants
Cirq Arm System (2.0) FDA 510(k)EUDAMED
Alignment System Spine FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cirq Arm System (2.0); Alignment System Spine is a robotic alignment device designed for spinal surgical procedures. It assists in precise screw placement by automatically aligning to pre- or intraoperatively planned trajectories, enhancing accuracy and workflow efficiency during spinal interventions.

This system is supplied as a modular robotic surgical platform and is intended for use in operating rooms. It is a passive, semi-rigid mechatronic device, with regulatory authorisations including FDA 510K clearance and MDR compliance. The device is reusable and requires proper handling and maintenance as per manufacturer guidelines to ensure optimal performance and sterility.

Frequently asked questions

What types of spinal surgical procedures is the Cirq Arm System (2.0) Alignment System Spine designed to assist with specifically?

The Cirq Arm System (2.0) is designed to assist with spinal surgical procedures by providing precise screw placement. It automates alignment to pre- or intraoperatively planned trajectories, which helps improve accuracy during interventions like pedicle screw fixation, laminoplasty, or other spinal stabilization surgeries. Its modular robotic platform is intended for use in operating rooms to enhance workflow efficiency.

Is the Cirq Arm System (2.0) reusable, and what maintenance is required to ensure its performance and sterility?

Yes, the Cirq Arm System (2.0) is a reusable device. To maintain optimal performance and sterility, it requires proper handling and adherence to the manufacturer’s guidelines for maintenance. This includes regular cleaning, sterilization procedures, and inspections to ensure the device remains functional and safe for repeated use in surgical settings.

How does the Cirq Arm System (2.0) differ from other robotic alignment systems in terms of its design and functionality?

The Cirq Arm System (2.0) is described as a passive, semi-rigid mechatronic device, meaning it relies on pre-planned trajectories for alignment rather than active robotic manipulation. This design assists surgeons in achieving precise screw placement for spinal procedures by automatically aligning to planned paths, improving workflow efficiency without requiring complex active movement. Its modular operating room setup distinguishes it from fully active robotic systems.

What regulatory pathways has the Cirq Arm System (2.0) followed, and what does this mean for its use in clinical settings?

The Cirq Arm System (2.0) has received FDA 510(k) clearance and MDR compliance, confirming its regulatory authorization for use in the U.S. and European markets. This means it has undergone evaluation to demonstrate substantial equivalence to existing devices (per FDA) and meets EU medical device regulations, ensuring it adheres to safety and performance standards before clinical deployment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cirq® for Spinal: Robotic Surgery Solution | Brainlab, Cirq® Robotics: Modular Robotic Surgery Solution | Brainlab, Cirq Arm System (2.0);Alignment System Spine (K222966 ... - fda ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (2)

  • FDA 510(k) K222966 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026