510(k) · Cleared
ClearedVertex Rcconstruction 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 Jun 29, 2012 as substantially equivalent to K090714 (Medtronic Sofamor Danek, 2009) and 3 other predicates after a 71-day review. Its family tree reaches back 4 generations to 2001. 23 later devices descend from it.
- Decided
- Jun 29, 2012
- Review
- 71 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K003780 (2001). 13 ancestors in all, the oldest K010249 (2001). 23 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
- 3 generations backK042524 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004
- 2 generations backK052376 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
- 1 generation backK090714 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
- This deviceK121191 Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc. · 2012
- Descendant · cites it directly · 22 of its ownK123906 Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 16 of its ownK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 8 of its ownK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- Descendant · 3 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K123906Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly22descendants
- K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · 2 generations on16descendants
- K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 3 generations on8descendants
- K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · 2 generations on8descendants
- K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003780 | Vertex Reconstruction System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −3 | K042524 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K052376 | Modification to: Vertex Reconstruction System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K121191 | Vertex Rcconstruction System | Medtronic Sofamor Danek, Inc. | 2012 | — |
| +1 | K123906 | Vertex Reconstruction System, Vertext Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | 5 |
| +3 | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | — |
| +3 | K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 1…e Date device(s) to which Number Cleared equivalence is claimed K090714 VERTEX® Reconstruction System, 4/17/09 VERTEX SELECT® Reconstruct… | 2009 |
| * | K082728 | Vertex Recontruction System, Vertex Select Reconstruction SystemSummary page 1…4/17/09 VERTEX SELECT® Reconstruction System K082728 VERTEX® Reconstruction System, 1/16/09 VERTEX SELECT® Reconstruc… | 2009 |
| * | K083071 | Vertex Reconstruction SystemSummary page 1…1/16/09 VERTEX SELECT® Reconstruction System K083071 VERTEX® Reconstruction System 11/14/08 K(042789 VERTEX® Reconstruction… | 2008 |
| * | K042789 | Vertex Reconstruction SystemSummary page 1…System K083071 VERTEX® Reconstruction System 11/14/08 K(042789 VERTEX® Reconstruction System 12/21/04 Reason for 510(k) The purpose of this 51 0(k) is to modify… | 2004 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123906 | Vertex Reconstruction System, Vertext Select Reconstruction System | 2013 | 22 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K123906 (Medtronic Sofamor Danek USA, Inc., 2013) has gone furthest, with 22 descendants of its own.
- 9 other devices also cite its predicate K090714.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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…
Read the full statement (297 words)
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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: Plate Rod/Plates/Rods/Occipital Screws/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 02 and below.
Nate: 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 (Cl - T3) spine.
Multi-axial Screws
The use of multi-axial screws is 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.
Connectors
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CID 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 screws, hooks, and 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/K121191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121191: Vertex Rcconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121191
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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