# K213978: TELIGEN System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Oct 18, 2022 after 302 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K002764 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191579: Voyant System, Viseon, Inc. (2019) Summary page 4.
- K122861: XTOOL, Ouroboros Medical (2012) Summary page 4.

## Indications for use
The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

Source page: https://510kreport.com/device/K213978
Methodology: https://510kreport.com/methodology