Benchmed logo
Categories

SYMPHONY Navigation Ready Instruments

Medos International SARL

Country / Region:Switzerland (CH)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

View Summary PDF

Company

Switzerland (CH)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K260240
Device name
SYMPHONY Navigation Ready Instruments
Country / Region
Switzerland(CH)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2026-01-26
Decision date
2026-03-27
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

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
• the use of SYMPHONY OCT System is indicated,
• the use of stereotactic surgery may be appropriate, and
• reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be:
• pre-calibrated with the VELYS™ SPINE Navigation using the VELYS™ SPINE Instrument Arrays,
• pre-calibrated and/or manually calibrated with the Brainlab Navigation System using the UNAS Navigation Arrays,
• manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.
The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial screw placement.

Intended Use

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which: • the use of SYMPHONY OCT System is indicated, • the use of stereotactic surgery may be appropriate, and • reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be: • pre-calibrated with the VELYS™ SPINE Navigation using the VELYS™ SPINE Instrument Arrays, • pre-calibrated and/or manually calibrated with the Brainlab Navigation System using the UNAS Navigation Arrays, • manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer. The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial screw placement.

Device Description

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS).

Summary parsed at:2026-06-19 04:31:30 UTC

Predicate devices

3

K260240 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K260240 as a predicate