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 USA, Inc. · NKG Posterior Cervical Screw System
Cleared on Apr 18, 2018 as substantially equivalent to K152338 (Medtronic Sofamor Danek USA, Inc., 2015) and 6 other predicates after a 16-day review. Its family tree reaches back 16 generations to 2004. 8 later devices descend from it.
- Decided
- Apr 18, 2018
- Review
- 16 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K040583 (2004). 137 ancestors in all, the oldest K841189 (1984). 8 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- This deviceK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK192646 SYMPHONY™ OCT SystemMedos International SARL · 2020
- Descendant · 2 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK203319 SYMPHONY™ OCT SystemMedos International SARL · 2021
- Descendant · 3 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- 3 generations backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- This deviceK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · cites it directly3descendants
- K192646SYMPHONY™ OCT SystemMedos International SARL · 2020 · cites it directly2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
- K203319SYMPHONY™ OCT SystemMedos International SARL · 2021 · 2 generations on1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| −3 | K152457 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K162379 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −1 | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | 5 |
| 0 (this device) | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +1 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +1 | K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020 | — |
| +2 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +2 | K203319 | SYMPHONY™ OCT System | Medos International SARL | 2021 | — |
| +3 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 25 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K152338 | VERTEX (r) Reconstruction SystemSummary page 4…on, Spinal Interlaminal (21 CFR§ 888.3050) Classification: Class II Product Code: KWP III. Predicate Device: Primary Predicate ! K152338 VERTEX™ Reconstruction System (S.E.10/28/2015) Additional Predicates ! K123656 VERTEX™ Reconstruction Syst… | 2015 |
| * | K123656 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 4…III. Predicate Device: Primary Predicate ! K152338 VERTEX™ Reconstruction System (S.E.10/28/2015) Additional Predicates ! K123656 VERTEX™ Reconstruction System (S.E.02/25/2013) ! K003780 VERTEX™ Reconstruction System (S.E. 09/28/2001) !… | 2013 |
| * | K003780 | Vertex Reconstruction SystemSummary page 4…52338 VERTEX™ Reconstruction System (S.E.10/28/2015) Additional Predicates ! K123656 VERTEX™ Reconstruction System (S.E.02/25/2013) ! K003780 VERTEX™ Reconstruction System (S.E. 09/28/2001) ! K052402 VERTEX™ Reconstruction System (S.E. 09/23/2005)… | 2001 |
| * | K052402 | Vertex Reconstruction SystemSummary page 4…al Predicates ! K123656 VERTEX™ Reconstruction System (S.E.02/25/2013) ! K003780 VERTEX™ Reconstruction System (S.E. 09/28/2001) ! K052402 VERTEX™ Reconstruction System (S.E. 09/23/2005) ! K070742 VERTEX™ Reconstruction System (S.E. 09/14/2007)… | 2005 |
| * | K070742 | Modification to Vertex Reconstruction SystemSummary page 4….02/25/2013) ! K003780 VERTEX™ Reconstruction System (S.E. 09/28/2001) ! K052402 VERTEX™ Reconstruction System (S.E. 09/23/2005) ! K070742 VERTEX™ Reconstruction System (S.E. 09/14/2007) ! K080805 VERTEX™ Reconstruction System (S.E. 04/18/2008)… | 2007 |
| * | K080805 | Modification to Vertex Reconstruction SystemSummary page 4…09/28/2001) ! K052402 VERTEX™ Reconstruction System (S.E. 09/23/2005) ! K070742 VERTEX™ Reconstruction System (S.E. 09/14/2007) ! K080805 VERTEX™ Reconstruction System (S.E. 04/18/2008) ! K163375 INFINITY™ OCT System (S.E. 08/21/2017)… | 2008 |
| * | K163375 | INFINITY™ OCT SystemSummary page 4…09/23/2005) ! K070742 VERTEX™ Reconstruction System (S.E. 09/14/2007) ! K080805 VERTEX™ Reconstruction System (S.E. 04/18/2008) ! K163375 INFINITY™ OCT System (S.E. 08/21/2017)… | 2017 |
What descends from it? (8)
3 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 14 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 15 of the 137 ancestors have a recall of any class.
- Of its descendants, K200936 (Alphatec Spine, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K152338.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180851: VERTEX™ 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/K180851
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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