# K223438: TELIGEN System Peripheral Motor Nerve Stimulation Indications

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Feb 10, 2023 after 88 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K983831 (1999). 53 ancestors in all.
No later device cites it as a predicate yet.
3 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173134: SENTIO MMG Pedicle Access Needles, Medos International SARL (2018) Summary page 4.
- K223108: TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear), Medos International SARL (2023). Cleared while this submission was under review Summary page 5.

## 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. The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

Source page: https://510kreport.com/device/K223438
Methodology: https://510kreport.com/methodology