510(k) · Cleared
ClearedVERTEX (r) Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NKG Posterior Cervical Screw System
Cleared on Oct 28, 2015 as substantially equivalent to K143471 (Medtronic Sofamor Danek USA, Inc., 2015) after a 70-day review. Its family tree reaches back 3 generations to 1997. 34 later devices descend from it.
- Decided
- Oct 28, 2015
- Review
- 70 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. 34 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 2 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 1 generation backK143471 VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK152338 VERTEX (r) Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 17 of its ownK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- Descendant · cites it directly · 16 of its ownK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- Descendant · cites it directly · 8 of its ownK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016 · cites it directly17descendants
- K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · cites it directly16descendants
- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
- K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018 · cites it directly8descendants
- K182182YUKON OCT Spinal SystemK2m · 2018 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −2 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −1 | K143471 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K152338 | VERTEX (r) Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| +1 | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | 5 |
| +2 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| +1 | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K182182 | YUKON OCT Spinal System | K2m | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 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 NKG? 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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 |
|---|---|---|---|
| * | K143471 | VERTEX Reconstruction SystemSummary page 4…II Product Code: KWP III. Predicate Devices: Primary Predicate – VERTEX® Reconstruction System K143471 (S.E. 02/06/2015) • Reference Device – VERTEX® Reconstruction… | 2015 |
| † | K003780 | Vertex Reconstruction System | 2001 |
| † | K022015 | Modification to Vertex Reconstruction System | 2002 |
| † | K042498 | Vertex Reconstruction System | 2004 |
| † | K052402 | Vertex Reconstruction System | 2005 |
| † | K052376 | Modification to: Vertex Reconstruction System | 2005 |
| † | K071942 | Modification to Vertex Reconstruction System | 2007 |
| † | K123906 | Vertex Reconstruction System, Vertext Select Reconstruction System | 2013 |
What descends from it? (34)
See all 345 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K153370 (K2m, Incorporated, 2016) has gone furthest, with 17 descendants of its own.
- 18 other devices also cite its predicate K143471.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The VERTEX® Reconstruction System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and…
Read the full statement (207 words)
The VERTEX® Reconstruction System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VERTEX® Reconstruction System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. 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/K152338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152338: VERTEX (r) Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152338
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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