# K260240: SYMPHONY Navigation Ready Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Mar 27, 2026 after 60 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K983831 (1999). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201661: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set, Medos International SARL (2020) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K260240
Methodology: https://510kreport.com/methodology