510(k) · Cleared
Recalled · Class II · 2022VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec AG · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 20, 2019 as substantially equivalent to K182377 (CarboFix Orthopedics, Ltd., 2018) and 3 other predicates after a 108-day review. Its family tree reaches back 17 generations to 2004. 29 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 17 generations to K040583 (2004). 272 ancestors in all, the oldest K841189 (1984). 29 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- 2 generations backK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 1 generation backK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- This deviceK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019
- Descendant · cites it directly · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · 2 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 6 of its ownK193423 VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2020 · Recalled
- Descendant · cites it directly · 5 of its ownK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023 · Recalled
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 4 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- 3 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- 2 generations backK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 1 generation backK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- This deviceK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · cites it directly27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 3 generations on11descendants
- K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2020 · cites it directly6descendants
- K222789VADER® Pedicle System, G21 CementIcotec AG · 2023 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −4 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| −3 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| −2 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| −1 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| 0 (this device) | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | — |
| +1 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +2 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2020 | 1 |
| +1 | K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 12 | 0 |
| 1999 | 16 | 0 |
| 2000 | 17 | 0 |
| 2001 | 18 | 0 |
| 2002 | 16 | 0 |
| 2003 | 18 | 0 |
| 2004 | 27 | 0 |
| 2005 | 20 | 0 |
| 2006 | 18 | 0 |
| 2007 | 12 | 0 |
| 2008 | 11 | 0 |
| 2009 | 10 | 0 |
| 2010 | 11 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182377 | CarboClear® Pedicle Screw SystemSummary page 5…ne. Primary Predicate Device: The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to the CarboFix CarboClear Pedicle System (K182377). Additional Predicate Devices: The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent… | 2018 |
| * | K151977 | icotec Pedicle SystemSummary page 5…Devices: The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are substantially equivalent to additional predicate devices: x icotec Pedicle System (K151977) x Blackstone Pedicle Screw System (K082797) x Corelink Tiger Spine System (K113058) Reference Device: The subject 510… | 2016 |
| * | K082797 | Blackstone Pedicle Screw SystemSummary page 5…ghtMore® Pedicle System 6.0 are substantially equivalent to additional predicate devices: x icotec Pedicle System (K151977) x Blackstone Pedicle Screw System (K082797) x Corelink Tiger Spine System (K113058) Reference Device: The subject 510(k) references the icotec Interbody Cage System (… | 2008 |
| * | K113058 | Tiger Spine SystemSummary page 5…equivalent to additional predicate devices: x icotec Pedicle System (K151977) x Blackstone Pedicle Screw System (K082797) x Corelink Tiger Spine System (K113058) Reference Device: The subject 510(k) references the icotec Interbody Cage System (K172480) since it has the same BlackArmor® ma… | 2012 |
| † | K172480 | icotec Interbody Cage System | 2018 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2022 | Class II | Z-0728-2023 | Nonconforming Material/Component | 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. The measuring results for both… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 8 companies; a new generation was cleared every 4 months on median.
- 30 of the 272 ancestors have a recall of any class.
- Of its descendants, K200596 (Icotec AG, 2020) has gone furthest, with 27 descendants of its own.
- 7 other devices also cite its predicate K182377.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190545
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026