510(k) · Cleared
Recalled · Class II · 2019neon3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · NKG Posterior Cervical Screw System
Cleared on Sep 24, 2015 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) after a 196-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 2015
- Review
- 196 days
- Class
- Class II
- Product code
- NKG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 2 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 1 generation backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- This deviceK150650 neon3Ulrich GmbH & Co. KG · 2015
- Descendant · cites it directly · 7 of its ownK161032 neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · 3 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · cites it directly · 1 of its ownK171250 BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical · 2017
- Descendant · 3 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG · 2016 · cites it directly7descendants
- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 2 generations on2descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 3 generations on1descendant
- K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical · 2017 · cites it directly1descendant
- K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −2 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −1 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| 0 (this device) | K150650 | neon3 | Ulrich GmbH & Co. KG | 2015 | — |
| +1 | K161032 | neon3™ universal OCT spinal stabilization | Ulrich GmbH & Co. KG | 2016 | 1 |
| +2 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +3 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +1 | K171250 | BRIDALVEIL Occipital Cervical Thoracic System | Astura Medical | 2017 | — |
| +3 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) SystemSummary page 4…Ti-6Al-4V titanium alloy (ASTM F136) or Cobalt Chrome (ASTM F1537) Primary Predicate: Synapse Occipital-Cervical-Thoracic (OCT) System (Synthes, K142838) Page 42… | 2015 |
| † | K070638 | Theken Atoll Cervico-Thoracic System | 2007 |
| † | K113346 | Neon System | 2012 |
| † | K151031 | Virage OCT Spinal Fixation System | 2015 |
| † | K990965 | Synthes Cervifix System | 1999 |
| † | K030377 | Modification to Synthes Cervifix System | 2003 |
| † | K011966 | CerviFix® System |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2019 | Class II | Z-1350-2020 | Process control | Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K161032 (Ulrich GmbH & Co. KG, 2016) has gone furthest, with 7 descendants of its own.
- 31 other devices also cite its predicate K142838.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
neon3™ 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 (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…
Read the full statement (130 words)
neon3™ 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 (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.
neon3™ 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150650 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150650: neon3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150650
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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