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Spine & Trauma Navigation Instruments

Brainlab AG

Country / Region:United States (US)Submission type:Special

Product code OLO· 21 CFR 882.4560

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Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252562
Device name
Spine & Trauma Navigation Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-08-14
Decision date
2025-09-12
Submission type
Special
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation SystemOther
Primary application
Spine Surgery
Classification source
AI classified

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 data based model of the anatomy.

Intended 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 data based model of the anatomy.

Device Description

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.

Summary parsed at:2026-06-19 05:25:17 UTC

Predicate devices

1
  • Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System

    Brainlab AG

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Cited as predicate

0

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