510(k) · Cleared
ClearedVertex Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 28, 2001 after a 295-day review. The FDA summary names no predicate by number. 1 of the 421 devices in its family, counting itself, has a Class I recall. 420 later devices descend from it.
- Decided
- Sep 28, 2001
- Review
- 295 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
420 later devices descend from it, 21 citing it directly. 1 of the 421 devices in this family, counting this one, has a Class I recall.
- This deviceK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
- Descendant · cites it directly · 373 of its ownK042524 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 325 of its ownK042789 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 262 of its ownK053483 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 259 of its ownK042402 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2004
- Descendant · cites it directly · 254 of its ownK052376 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
Showing 5 of 420 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 420 · See all- K042524Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004 · cites it directly373descendants
- K042789Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004 · cites it directly325descendants
- K053483Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2006 · 2 generations on262descendants
- K042402Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly259descendants
- K052376Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · cites it directly254descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003780 | Vertex Reconstruction System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| +1 | K042524 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K042789 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2004 | — |
| +2 | K053483 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K042402 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| +1 | K052376 | Modification to: Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 17 | 0 |
| 2013 | 19 | 0 |
| 2014 | 21 | 0 |
| 2015 | 25 | 0 |
| 2016 | 19 | 0 |
| 2017 | 20 | 0 |
| 2018 | 21 | 0 |
| 2019 | 17 | 0 |
| 2020 | 22 | 0 |
| 2021 | 22 | 1 |
| 2022 | 24 | 0 |
| 2023 | 38 | 0 |
| 2024 | 37 | 0 |
| 2025 | 30 | 0 |
| 2026 | 36 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (420)
See all 42021 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042524 | Modification to Vertex Reconstruction System | 2004 | 373 |
| K042789 | Vertex Reconstruction System | 2004 | 325 |
| K042402 | Modification to Vertex Reconstruction System | 2004 | 259 |
| K052376 | Modification to: Vertex Reconstruction System | 2005 | 254 |
| K090714 | Vertex Reconstruction System, Vertex Select Reconstruction System | 2009 | 233 |
| K042498 | Vertex Reconstruction System | 2004 | 188 |
| K050391 | Protex CT Cervicothoracic Spinal System | 2005 | 148 |
| K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | 2011 | 106 |
| K070638 | Theken Atoll Cervico-Thoracic System | 2007 | 59 |
| K133556 | Virage Oct Spinal Fixation System | 2014 | 27 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042524 (Medtronic Sofamor Danek, 2004) has gone furthest, with 373 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to promote fusion of the cervical spine and the thoracic spine Cl T3 the VERTE3P Reconstruction System is indicated for the following DDD neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis spinal stenosis fracture dislocation failed previous fusion and or tumors Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following…
Read the full statement (154 words)
When intended to promote fusion of the cervical spine and the thoracic spine Cl T3 the VERTE3P Reconstruction System is indicated for the following
DDD neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis spinal stenosis fracture dislocation failed previous fusion and or tumors
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture dislocation or trauma in the cervical upper thoracic C 1 T3 spine
Multi axial Screws Lateral Connectors
The use of multi axial screws 3 5mm and 4 0mm cancellous and 4 0mm cortical is limited to placement in Tl T3 in treating thoracic conditions only The multi axial screws are not intended to be placed in the cervical spine
Titanium ATLAS Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K003780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003780: Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003780
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026