510(k) · Cleared
ClearedCortium™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich Medical USA · NKG Posterior Cervical Screw System
Cleared on May 2, 2023 as substantially equivalent to K161032 (Ulrich GmbH & Co. KG, 2016) and 3 other predicates after a 57-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- May 2, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K003155 (2001). 99 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 backK113346 Neon SystemUlrich GmbH & Co. KG · 2012
- This deviceK230614 Cortium™Ulrich Medical USA · 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 backK113346 Neon SystemUlrich GmbH & Co. KG · 2012
- This deviceK230614 Cortium™Ulrich Medical USA · 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 | K113346 | Neon System | Ulrich GmbH & Co. KG | 2012 | — |
| 0 (this device) | K230614 | Cortium™ | Ulrich Medical USA | 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 | 9 | 0 |
| 2004 | 21 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 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? (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 |
|---|---|---|---|
| * | K161032 | neon3™ universal OCT spinal stabilizationSummary page 4…M F1537). Instruments are predominantly manufactured from stainless steels per ASTM F899. Primary Predicate: neon3™ (ulrich GmbH & Co KG – K161032) Additional Predicates: CerviFix StarLock System (Synthes USA – K994187), neon3™ (ulrich GmbH & Co KG… | 2016 |
| * | K994187 | Synthes Cervifix SystemSummary page 4…red from stainless steels per ASTM F899. Primary Predicate: neon3™ (ulrich GmbH & Co KG – K161032) Additional Predicates: CerviFix StarLock System (Synthes USA – K994187), neon3™ (ulrich GmbH & Co KG – K150650), neon system (ulrich GmbH & Co KG – K113346)… | 1999 |
| * | K150650 | neon3Summary page 4…neon3™ (ulrich GmbH & Co KG – K161032) Additional Predicates: CerviFix StarLock System (Synthes USA – K994187), neon3™ (ulrich GmbH & Co KG – K150650), neon system (ulrich GmbH & Co KG – K113346)… | 2015 |
| * | K113346 | Neon SystemSummary page 4…ional Predicates: CerviFix StarLock System (Synthes USA – K994187), neon3™ (ulrich GmbH & Co KG – K150650), neon system (ulrich GmbH & Co KG – K113346) K230614 - Page 2 of 2 Performance… | 2012 |
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.
- 10 of the 99 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?
Cortium is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine…
Read the full statement (171 words)
Cortium is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic 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.
Cortium 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, Cortium can also be connected to Momentum via transition rods or connectors. Please refer to the Momentum Instructions for Use for a list of indications for 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/K230614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230614: Cortium™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230614
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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