# K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Aug 30, 2022 after 88 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: 8 generations back to K983831 (1999). 32 ancestors in all.
6 later devices descend from it; 5 cite it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212245: Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning, Brainlab AG (2022) Summary page 4.
- K110204: Brainlab Trauma, Brainlab AG (2011) Summary page 4.
- 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.

## Most influential descendants
- 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
- K252562: Spine & Trauma Navigation Instruments (2025), 0 descendants of its own
- K242569: Mixed Reality Spine Navigation (2025), 0 descendants of its own

## Indications for use
Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data. Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy. 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/K221618
Methodology: https://510kreport.com/methodology