# K120867: Viper and Expedium Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Sep 20, 2012 after 182 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: 5 generations back to K983831 (1999). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070106: VV Fluoro 3D, Brainlab AG (2007) Summary page 1.

## Most influential descendants
- K140927: Universal Navigation Instruments (2014), 1 descendant of its own
- K192495: Black Diamond Navigation Instruments (2020), 0 descendants of its own

## Indications for use
The VIPER®)and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER@ and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra 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.

Source page: https://510kreport.com/device/K120867
Methodology: https://510kreport.com/methodology