510(k) · Cleared
ClearedVADER® Pedicle System
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 Feb 26, 2024 as substantially equivalent to K222789 (Icotec AG, 2023) after a 181-day review. Its family tree reaches back 22 generations to 2004. 1 of the 338 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 26, 2024
- Review
- 181 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K040583 (2004). 336 ancestors in all, the oldest P810020 (1984). 1 later device descends from it, 1 citing it directly. 1 of the 338 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 2 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- 1 generation backK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023 · Recalled
- This deviceK232628 VADER® Pedicle SystemIcotec AG · 2024
- Descendant · cites it directly · 0 of its ownK242900 VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG · 2025
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 8 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 6 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 5 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 4 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- 3 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 2 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- 1 generation backK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023 · Recalled
- This deviceK232628 VADER® Pedicle SystemIcotec AG · 2024
Class I recalls in this family
- K100952 Modification to Synthes Matrix System8 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −8 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −6 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −5 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −4 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| −3 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| −2 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| −1 | K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023 | 2 |
| 0 (this device) | K232628 | VADER® Pedicle System | Icotec AG | 2024 | — |
| +1 | K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 14 | 0 |
| 1999 | 16 | 0 |
| 2000 | 20 | 0 |
| 2001 | 20 | 0 |
| 2002 | 17 | 0 |
| 2003 | 21 | 0 |
| 2004 | 31 | 0 |
| 2005 | 24 | 0 |
| 2006 | 19 | 0 |
| 2007 | 16 | 0 |
| 2008 | 13 | 0 |
| 2009 | 16 | 0 |
| 2010 | 15 | 1 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K222789 | VADER® Pedicle System, G21 CementSummary page 6…fixations in the non-cervical spine. Primary Predicate Device: The subject icotec VADER® Pedicle System is substantially equivalent to the icotec VADER® Pedicle System (K222789). Performance Testing Summary: Clinical data was presented to support the expanded indications for use. The clinical data provid… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 42 of the 336 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242900 (Icotec AG, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K222789.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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® 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…
Read the full statement (225 words)
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 sufficient 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.
The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232628: VADER® Pedicle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232628
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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