510(k) · Cleared
ClearedEdge Upper Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Simplicity, LLC · NKG Posterior Cervical Screw System
Cleared on Jul 10, 2023 as substantially equivalent to K161032 (Ulrich GmbH & Co. KG, 2016) after a 431-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- Jul 10, 2023
- Review
- 431 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K003155 (2001). 93 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 2 generations backK073420 Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc. · 2008
- 1 generation backK161032 neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG · 2016 · Recalled
- This deviceK221307 Edge Upper Cervical SystemSpinal Simplicity, LLC · 2023
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 4 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 2 generations backK073420 Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc. · 2008
- 1 generation backK161032 neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG · 2016 · Recalled
- This deviceK221307 Edge Upper Cervical SystemSpinal Simplicity, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −4 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −2 | K073420 | Blackstone Ascent Multiaxial Screws | Blackstone Medical, Inc. | 2008 | — |
| −1 | K161032 | neon3™ universal OCT spinal stabilization | Ulrich GmbH & Co. KG | 2016 | 1 |
| 0 (this device) | K221307 | Edge Upper Cervical System | Spinal Simplicity, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 21 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K161032 | neon3™ universal OCT spinal stabilizationSummary page 4…Class II / Appliance, Fixation, Spinal Interlaminal, 21 CFR 888.3050, Class II Product codes: NKG/KWP Predicate Devices: neon3™ universal OCT by ulrich GmbH & Co. KG (K161032) – Primary Predicate Depuy Synthes Symphony OCT System (K192646) – Reference Device Medtronic Vertex Select (K123906) – Reference… | 2016 |
| † | K192646 | SYMPHONY™ OCT System | 2020 |
| † | K123906 | Vertex Reconstruction System, Vertext Select Reconstruction System | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 8 of the 93 ancestors have a recall of any class.
- 4 other devices also cite its predicate K161032.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Edge upper cervical 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 cervical spine (Cl to C7) and the thoracic spine (TI to T3): * Traumatic spinal fractures and/or traumatic dislocations; * instability or deformity; * failed previous fusions (e.g., pseudarthrosis); * tumors involving the cervical/thoracic spine; * degenerative disease…
Read the full statement (156 words)
The Edge upper cervical 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 cervical spine (Cl to C7) and the thoracic spine (TI to T3):
* Traumatic spinal fractures and/or traumatic dislocations;
* instability or deformity;
* failed previous fusions (e.g., pseudarthrosis);
* tumors involving the cervical/thoracic spine;
* 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 Edge UCS 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. The Edge UCS is intended for use only with the Innosys AnaxTM OCT Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221307: Edge Upper Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221307
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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