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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

Country / Region:Germany (DE)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Germany (DE)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

6

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
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

2

K212245 references 2 predicate/reference devices

Cited as predicate

6

6 submissions cite K212245 as a predicate