510(k) · Cleared
ClearedVertex Reconstruction System and Vertex Select Reconstruction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 2, 2009 as substantially equivalent to K042789 (Medtronic Sofamor Danek, 2004) and 6 other predicates after a 28-day review. Its family tree reaches back 12 generations to 2001. 7 later devices descend from it.
- Decided
- Dec 2, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K003155 (2001). 77 ancestors in all, the oldest K841189 (1984). 7 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 2 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- This deviceK093434 Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
- Descendant · cites it directly · 5 of its ownK111076 Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK182837 M.U.S.T. Mini ExtensionMedacta International S.A. · 2019
- Descendant · 2 generations on · 1 of its ownK162266 The Cranial Fusion SystemLife Spine, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK203125 Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK203149 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 2 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- This deviceK093434 Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011 · cites it directly5descendants
- K182837M.U.S.T. Mini ExtensionMedacta International S.A. · 2019 · 2 generations on1descendant
- K162266The Cranial Fusion SystemLife Spine, Inc. · 2017 · 2 generations on1descendant
- K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on0descendants
- K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −2 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −1 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K093434 | Vertex Reconstruction System and Vertex Select Reconstruction System | Medtronic Sofamor Danek | 2009 | — |
| +1 | K111076 | Solanas Avalon Posterior Fixation System | Alphatec Spine, Inc. | 2011 | — |
| +2 | K182837 | M.U.S.T. Mini Extension | Medacta International S.A. | 2019 | — |
| +2 | K162266 | The Cranial Fusion System | Life Spine, Inc. | 2017 | — |
| +2 | K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +3 | K203149 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 17 | 0 |
| 2005 | 9 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K042789 | Vertex Reconstruction SystemSummary page 2…ially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX®D Reconstruction System in K042789 (S.F. 12/21/04), K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K09071… | 2004 |
| * | K070742 | Modification to Vertex Reconstruction SystemSummary page 2…commercially available posterior fixation systems and other pre-enactment devices including the VERTEX®D Reconstruction System in K042789 (S.F. 12/21/04), K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K090714 (S.F. 4/17/09) a… | 2007 |
| * | K071942 | Modification to Vertex Reconstruction SystemSummary page 2…posterior fixation systems and other pre-enactment devices including the VERTEX®D Reconstruction System in K042789 (S.F. 12/21/04), K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K090714 (S.F. 4/17/09) and in CD HORIZON® Spinal System… | 2007 |
| * | K080805 | Modification to Vertex Reconstruction SystemSummary page 2…and other pre-enactment devices including the VERTEX®D Reconstruction System in K042789 (S.F. 12/21/04), K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K090714 (S.F. 4/17/09) and in CD HORIZON® Spinal System K043488 (S.E. 3/21/05). T… | 2008 |
| * | K082728 | Vertex Recontruction System, Vertex Select Reconstruction SystemSummary page 2…evices including the VERTEX®D Reconstruction System in K042789 (S.F. 12/21/04), K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K090714 (S.F. 4/17/09) and in CD HORIZON® Spinal System K043488 (S.E. 3/21/05). The results of mech… | 2009 |
| * | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 2…VERTEX®D Reconstruction System in K042789 (S.F. 12/21/04), K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K090714 (S.F. 4/17/09) and in CD HORIZON® Spinal System K043488 (S.E. 3/21/05). The results of mechanical testing performed… | 2009 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 2…K070742 (S.E. 9/14/07), K071942 (S.E. 12/11/07), K(080805 (S.E. 4/18/08), K(082728 (S.E. 1/16/09), K090714 (S.F. 4/17/09) and in CD HORIZON® Spinal System K043488 (S.E. 3/21/05). The results of mechanical testing performed for the subject VERTEX® Reconstruction System component… | 2005 |
What descends from it? (7)
2 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 8 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 5 of the 77 ancestors have a recall of any class.
- Of its descendants, K111076 (Alphatec Spine, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K042789.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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 (269 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 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/K093434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093434: Vertex Reconstruction System and Vertex Select 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/K093434
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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