# K193423: VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: May 22, 2020 after 165 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: 18 generations back to K040583 (2004). 273 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 280 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0, Icotec AG (2019) 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.
- K182377: CarboClear® Pedicle Screw System, CarboFix Orthopedics, Ltd. (2018) Summary page 5.

## Cited in the summary but kept off the family tree
- K190066: Medtronic CD Horizon Astute Spinal System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K233944: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (2024), 3 descendants of its own
- 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
- K242900: VADER® Pedicle System and VADER®one Pedicle System (2025), 0 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K193423
Methodology: https://510kreport.com/methodology