# K140927: Universal Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Oct 24, 2014 after 196 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: 6 generations back to K983831 (1999). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120867: Viper and Expedium Navigated Instruments, Medos International SARL (2012) Summary page 4.
- K122211: Synthes Navigable Pedicle Preparation Instruments, Synthes Spine (2012) Summary page 4.
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 4.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 4.

## Most influential descendants
- K192495: Black Diamond Navigation Instruments (2020), 0 descendants of its own

## Indications for use
The Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or 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 tracking arrays provided by the navigation manufacturer. These procedures include but are not limited to spinal fusion. These devices can be pre-calibrated and/or manually calibrated with Brainlab Navigation system, where other navigation systems require manual calibration.

Source page: https://510kreport.com/device/K140927
Methodology: https://510kreport.com/methodology