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Drill Guide; Drill Bit; Spine & Trauma Navigation

Brainlab AG

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

Product code OLO· 21 CFR 882.4560

Summary PDF

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
K240701
Device name
Drill Guide; Drill Bit; Spine & Trauma Navigation
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-03-14
Decision date
2024-05-23
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 databased 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 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. 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. Modified Drill Guides and Drill Bits have been introduced as part of the Subject Device. The Drill Guide instruments are navigated instruments which support the surgeon in guiding drill bits and K-wires during spinal procedures. They consist of a guide tube, a trocar insert (both available in five different diameters), a body with two available handles, an array and a depth control (available in two different sizes for various drilling depths). The Drill Guide Tubes and Drill Guide Trocar Inserts have patient contact. All instruments are delivered unsterile and require end user.

Summary parsed at:2026-06-19 05:31:25 UTC

Predicate devices

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

    Brainlab AG

K240701 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K240701 as a predicate