# K222966: Cirq Arm System (2.0);Alignment System Spine

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Oct 27, 2022 after 30 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K983831 (1999). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202320: CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System, Brainlab AG (2020) Summary page 4.

## Recalls of this device
- Mar 2, 2023 · Class II · Z-1292-2023: Risk of mechanical instability due to potential manufacturing error of the device

## Indications for use
As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.

Source page: https://510kreport.com/device/K222966
Methodology: https://510kreport.com/methodology