Manufacturer
Brainlab AGSpine 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
Country / Region:Germany (DE)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K212245
- Device name
- 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
- Company
- Brainlab AG
- Country / Region
- Germany(DE)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2021-07-19
- Decision date
- 2022-04-13
- Submission type
- Traditional
- 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 System 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 System 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, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
Intended Use
Spine & Trauma Navigation System 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. 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, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. Spine Planning is intended for pre- and intraoperative planning of open- and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.
Device Description
The Subject Device Spine and Trauma Navigation System consists of the following software's and hardware. Software: 1. Spine & Trauma 3D Navigation 1.5 enables navigation of instruments using the Spine & Trauma Navigation System. 2. Instrument Selection 1.6 lists all the available instruments by manufacturer, type, description and article number. 3. Fluoro 3D 1.0 enables registration of patient scans in the Spine & Trauma Navigation System. 4. Registration Software Paired Point 3.5 is a touchscreen-based intraoperative registration software. 5. Registration Software Spine Surface Matching 1.0 is a touchscreen-based intraoperative registration software. 6. Spine Planning 1.0 allows planning of screws for surgical navigation. Hardware: The Hardware accessories for the Subject Device are Platforms and Surgical Instruments.
Summary parsed at:2026-06-24 04:13:52 UTC
Predicate devices
2Cited as predicate
6Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Vital™ Navigation System
Virage® Navigation System
6 submissions cite K212245 as a predicate
