# K222789: VADER® Pedicle System, G21 Cement

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Jan 9, 2023 after 116 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K040583 (2004). 335 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 341 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200596: G21 Cement, VADER® Pedicle System, Icotec AG (2020) Summary page 7.
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0, Icotec AG (2019) Summary page 7.
- K151977: icotec Pedicle System, Icotec AG (2016) Summary page 7.

## Most influential descendants
- K240846: CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement (2024), 2 descendants of its own
- K233793: CarboClear® X Pedicle Screw System (2024), 1 descendant of its own
- K232628: VADER® Pedicle System (2024), 1 descendant of its own
- K242900: VADER® Pedicle System and VADER®one Pedicle System (2025), 0 descendants of its own
- K243106: CarboClear® Hybrid Pedicle Screw System (2024), 0 descendants of its own

## Recalls of this device
- Nov 28, 2023 · Class II · Z-0700-2024: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiti
- Nov 28, 2023 · Class II · Z-0701-2024: icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiti

## Indications for use
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™ 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 G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery. When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving 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 G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K222789
Methodology: https://510kreport.com/methodology