Manufacturer
Brainlab AGSpine & Trauma Navigation Instruments
Country / Region:United States (US)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252562
- Device name
- Spine & Trauma Navigation Instruments
- Company
- Brainlab AG
- 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
1Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
K252562 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252562 as a predicate
