Manufacturer
Medos International SARLSYMPHONY Navigation Ready Instruments
Country / Region:Switzerland (CH)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260240
- Device name
- SYMPHONY Navigation Ready Instruments
- Company
- Medos International SARL
- 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—
—
Not ingested
Spine Navigation and Robotic-Assistance Device
TELIGEN System Navigation Ready Instruments
K260240 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260240 as a predicate
