510(k) · Cleared
Recalled · Class II · 2020Vertex Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 11, 2008 after a 35-day review. The FDA summary names its predicate without a number. 239 later devices descend from it. It has been recalled once.
- Decided
- Jun 11, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 0
239 later devices descend from it, 2 citing it directly.
- This deviceK081297 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2008
- Descendant · cites it directly · 223 of its ownK083071 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2008 · Recalled
- Descendant · cites it directly · 146 of its ownK082728 Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2009
- Descendant · 2 generations on · 138 of its ownK091365 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009
- Descendant · 2 generations on · 128 of its ownK111510 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · 3 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
Showing 5 of 239 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 239 · See all- K083071Vertex Reconstruction SystemMedtronic Sofamor Danek · 2008 · cites it directly223descendants
- K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2009 · cites it directly146descendants
- K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009 · 2 generations on138descendants
- K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 2 generations on128descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · 3 generations on127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081297 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2008 | — |
| +1 | K083071 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2008 | 1 |
| +1 | K082728 | Vertex Recontruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2009 | — |
| +2 | K091365 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Soafamor Danek | 2009 | — |
| +2 | K111510 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +3 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 13 | 0 |
| 2014 | 15 | 0 |
| 2015 | 16 | 0 |
| 2016 | 12 | 0 |
| 2017 | 18 | 0 |
| 2018 | 17 | 0 |
| 2019 | 11 | 0 |
| 2020 | 18 | 0 |
| 2021 | 12 | 0 |
| 2022 | 18 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 0 |
| 2026 | 17 | 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 KWP? 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? (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 |
|---|---|---|---|
| * | — | VERTEX® Reconstruction System Named without a submission number |
What descends from it? (239)
See all 2392 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 |
|---|---|---|---|---|
| Mar 26, 2020 | Class II | Z-1941-2020 | Nonconforming Material/Component | Nonconforming product; length of the product measured shorter than the labeled length. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083071 (Medtronic Sofamor Danek, 2008) has gone furthest, with 223 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. 2008, this device’s year, is highlighted.
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 occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® 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. Occipitocervical Components…
Read the full statement (257 words)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® 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.
Occipitocervical Components: PlateRod/Plates/Rods/OccipitalScrews/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.
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 (C1-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws are limited to placement in T1-T3. The 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.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081297: Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081297
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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