# K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Jun 20, 2019 after 108 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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: 17 generations back to K040583 (2004). 272 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 302 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182377: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 5.
- K151977: icotec Pedicle System, Icotec AG (2016) Summary page 5.
- K082797: Blackstone Pedicle Screw System, Blackstone Medical, Inc. (2008) Summary page 5.
- K113058: Tiger Spine System, Corelink, LLC (2012) Summary page 5.

## Most influential descendants
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own
- 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
- K193423: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (2020), 6 descendants of its own
- K222789: VADER® Pedicle System, G21 Cement (2023), 5 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
The VADER® one Pedicle System MIS and LightMore® Pedicle System 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 is of insufficient duration to permit achievement of fusion. The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.

Source page: https://510kreport.com/device/K190545
Methodology: https://510kreport.com/methodology