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

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

3

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K221618
Device name
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
Country / Region
Germany(DE)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-06-03
Decision date
2022-08-30
Submission type
Traditional
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
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 databased model of the anatomy.

As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.

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. 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 databased 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 coming from the compatible imaging device LoopX. It offers different patient image registration methods and instrument selection and calibration to allow surgical navigation by using optical tracking technology. The software is installed on a mobile or fixed Image Guided Surgery (IGS) platform to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms comprise of a mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera for image guided surgery purposes. The Spine & Trauma Navigation consists of the following components: Software enabling instrument selection, different registration methods (e.g. surface matching) as well as navigation in different types of images; IGS platforms; Surgical instruments for navigation, patient referencing and registration. The Alignment System Spine is an accessory to the Spine & Trauma Navigation. It serves as a holding and positioning system to support the surgeon in reaching a pre-defined screw with surgical instruments.

Summary parsed at:2026-06-24 04:36:06 UTC

Predicate devices

3
  • Not ingested

  • Not ingested

  • 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

K221618 references 3 predicate/reference devices

Cited as predicate

4

4 submissions cite K221618 as a predicate