510(k) · Cleared
Recalled · Class II · 2023VADER® Pedicle System, G21 Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec AG · PML Bone Cement, Posterior Screw Augmentation
Cleared on Jan 9, 2023 as substantially equivalent to K200596 (Icotec AG, 2020) and 2 other predicates after a 116-day review. Its family tree reaches back 21 generations to 2004. 1 of the 341 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 9, 2023
- Review
- 116 days
- Class
- Class II
- Product code
- PML
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 21 generations to K040583 (2004). 335 ancestors in all, the oldest P810020 (1984). 5 later devices descend from it, 2 citing it directly. 1 of the 341 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations between
- 3 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- 2 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 1 generation backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- This deviceK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023
- Descendant · cites it directly · 2 of its ownK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK232628 VADER® Pedicle SystemIcotec AG · 2024
- Descendant · 2 generations on · 0 of its ownK242900 VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG · 2025
- Descendant · 2 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 21 generations
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 6 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 5 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 4 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 3 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- 2 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 1 generation backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- This deviceK222789 VADER® Pedicle System, G21 CementIcotec AG · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System7 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · cites it directly2descendants
- K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on1descendant
- K232628VADER® Pedicle SystemIcotec AG · 2024 · cites it directly1descendant
- K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG · 2025 · 2 generations on0descendants
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −18 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −16 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −13 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −12 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −11 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −10 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −9 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −6 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −5 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −4 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −3 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| −2 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| −1 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| 0 (this device) | K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023 | — |
| +1 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated… | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K232628 | VADER® Pedicle System | Icotec AG | 2024 | — |
| +2 | K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | 2025 | — |
| +2 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2024 | 4 | 0 |
| 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 PML device
- #1 K200596 G21 Cement, VADER® Pedicle Systemscore 24.9 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K200596 | G21 Cement, VADER® Pedicle SystemSummary page 7…Primary Predicate Device: The subject icotec VADER® Pedicle System is substantially equivalent to the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement (K200596). Additional Predicate Devices • VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) • icotec Pedicle S… | 2020 |
| * | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Summary page 7…c VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement (K200596). Additional Predicate Devices • VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) • icotec Pedicle System (K151977) Performance Testing Summary: Mechanical testing was performed per ASTM F1717 (static/dynami… | 2019 |
| * | K151977 | icotec Pedicle SystemSummary page 7…and V-Steady Bone Cement (K200596). Additional Predicate Devices • VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) • icotec Pedicle System (K151977) Performance Testing Summary: Mechanical testing was performed per ASTM F1717 (static/dynamic compression bending, static torsio… | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2023 | Class II | Z-0700-2024 | Other | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to… |
| Nov 28, 2023 | Class II | Z-0701-2024 | Other | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to… |
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 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 7 months on median.
- 41 of the 335 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240846 (CarboFix Orthopedics, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K200596.
How does its category compare?
All PML devicesPML Bone Cement, Posterior Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PML
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PML
116in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PML
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PML
55in 2025
MAUDE reports naming product code PML, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 35 |
| 2020 | 3 | 182 | 0 | 27 |
| 2021 | 1 | — | 0 | 32 |
| 2022 | 2 | — | 0 | 12 |
| 2023 | 3 | 116 | 2 | 18 |
| 2024 | 1 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 2 | — | 0 | — |
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 (285 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 insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws 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.
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® 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222789: VADER® Pedicle System, G21 Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222789
Report an extraction error
Are you the manufacturer?
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