# K200596: G21 Cement, VADER® Pedicle System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Oct 13, 2020 after 221 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 334 ancestors in all.
27 later devices descend from it; 7 cite it directly.
1 of 362 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150408: V-Steady, V-Fast, G21, S.R.L. (2015) 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.
- K082797: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 7.
- K113058: Tiger Spine System, Corelink, LLC (2012) Summary page 7.
- K182377: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 7.
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws, CarboFix Orthopedics, Ltd. (2019) Summary page 7.

## Most influential descendants
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K222789: VADER® Pedicle System, G21 Cement (2023), 5 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K231280: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (2023), 4 descendants of its own

## Recalls of this device
- Nov 3, 2022 · Class II · Z-0728-2023: During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. T

## Indications for use
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® one pedicle screws 6.0 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. 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 6.0 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 6.0 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.

Source page: https://510kreport.com/device/K200596
Methodology: https://510kreport.com/methodology