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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 data based model of the anatomy.

The Spine & Trauma Navigation is an image guided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use image data based on CT, MR, 3D fluoroscopic image reconstruction (cone beam CT) or 2D fluoroscopic images. It offers
different patient image registration methods and instrument calibrations to allow surgical navigation by using optical tracking technology. To fulfil this purpose, it consists of software, Image Guided Surgery platforms and surgical instruments.

Brainlab´s spinal instrument portfolio includes common types of instruments used in image guided surgery procedures including patient referencing instruments, instruments for image registration, drill guides, drill bits, tracking arrays, awls and probes for open surgery, Starlink instrument adapters and arrays to allow the connection of suitable 3rd party instruments, an Instrument Calibration Matrix for calibration of instruments, sets of instruments to be used with the accessories Microscope Navigation and Cirq Arm System, the sterile instruments Disposable Trocar Insert Pedicle Access Needle and Disposable Clip-On Remote Control and Sterilization Trays.

Modified spine reference clamps and Sterilization Trays have been introduced as part of the Subject Device. The new Patient Reference Rod-Clamp Spine & Trauma belongs to the Patient Reference Clamp Spine & Trauma group, consisting of 3 clamps, two intended to achieve a rigid fixation to the bone and a third one intended to achieve rigid fixation to a rod. This provides a solid interface for stiff reference array fixation, enabling navigated surgery with the Spine & Trauma Navigation software. The novel feature is the possibility to attach the clamp to an existing rod, which is only possible with the Patient Reference Rod-Clamp Spine & Trauma. All clamps are delivered unsterile and require end user sterilization.

The Sterilization Trays serve as a rigid containment device intended for the repeated use before, during and after sterilization in healthcare facilities to store, organize, identify and transport a set of specified instruments, which require sterilization prior to use. The Sterilization Tray requires an additional sterile barrier system to maintain sterile. There are multiple variants of the Sterilization Trays, each offering designated slots and outlines to a defined set of compatible instruments.

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