# K242900: VADER® Pedicle System and VADER®one Pedicle System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Feb 27, 2025 after 157 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K040583 (2004). 381 ancestors in all.
No later device cites it as a predicate yet.
1 of 382 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232628: VADER® Pedicle System, Icotec AG (2024) Summary page 6.
- K193423: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0, Icotec AG (2020) Summary page 6.
- K133369: Tiger Spine System, Corelink, LLC (2014) Summary page 6.

## Indications for use
The VADER@ Pedicle System: The VADER@ Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix"m V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER@ pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER@ pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER@ Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. The VADER@ Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery. VADER~one Pedicle System: The VADER @one Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The VADERgone Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

Source page: https://510kreport.com/device/K242900
Methodology: https://510kreport.com/methodology