# K223108: TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jan 19, 2023 after 111 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: 9 generations back to K983831 (1999). 23 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122211: Synthes Navigable Pedicle Preparation Instruments, Synthes Spine (2012) Summary page 4.
- K212756: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set, Medos International SARL (2022) Summary page 4.

## Most influential descendants
- K233254: TELIGEN System Navigation Ready Instruments (2024), 2 descendants of its own
- K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (2024), 1 descendant of its own
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (2026), 0 descendants of its own
- K223438: TELIGEN System Peripheral Motor Nerve Stimulation Indications (2023), 0 descendants of its own

## 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. The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which: • the use of stereotactic surgery may be appropriate, and • 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 a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. TELIGEN Clear, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

Source page: https://510kreport.com/device/K223108
Methodology: https://510kreport.com/methodology