510(k) · Cleared
ClearedNeon System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 28, 2012 as substantially equivalent to K033980 (Blackstone Medical, Inc., 2004) and 7 other predicates after a 106-day review. Its family tree reaches back 13 generations to 2001. 1 later device descends from it.
- Decided
- Feb 28, 2012
- Review
- 106 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 13 generations to K003155 (2001). 90 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 1 generation backK073420 Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc. · 2008
- This deviceK113346 Neon SystemUlrich GmbH & Co. KG · 2012
- Descendant · cites it directly · 0 of its ownK230614 Cortium™Ulrich Medical USA · 2023
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 1 generation backK073420 Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc. · 2008
- This deviceK113346 Neon SystemUlrich GmbH & Co. KG · 2012
Most influential descendants
Showing 1 of 1 · See all- K230614Cortium™Ulrich Medical USA · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −3 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −2 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −1 | K073420 | Blackstone Ascent Multiaxial Screws | Blackstone Medical, Inc. | 2008 | — |
| 0 (this device) | K113346 | Neon System | Ulrich GmbH & Co. KG | 2012 | — |
| +1 | K230614 | Cortium™ | Ulrich Medical USA | 2023 | — |
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 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 21 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K033980 | Blackstone Ascent Poct System Hooks (System Modification) Our reading of the summary gave K033480, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ascent POCT System”. | 2004 |
| * | K073420 | Blackstone Ascent Multiaxial ScrewsSummary page 2…rade 2, ASTM F67) or titanium alloy (Ti-6A1-4V) as described by ASTM F136: Predicate Devices: Ascent POCT System (K033480 and K073420) Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060)… | 2008 |
| * | K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSummary page 2…bed by ASTM F136: Predicate Devices: Ascent POCT System (K033480 and K073420) Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060) CerviFix@ System (K030377 and K01 1966) Technological… | 2003 |
| * | K052566 | Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119…Summary page 2…F136: Predicate Devices: Ascent POCT System (K033480 and K073420) Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060) CerviFix@ System (K030377 and K01 1966) Technological neonTM possesses the same… | 2006 |
| * | K062505 | Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesSummary page 2…Predicate Devices: Ascent POCT System (K033480 and K073420) Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060) CerviFix@ System (K030377 and K01 1966) Technological neonTM possesses the same technolo… | 2006 |
| * | K090060 | Nexlink Oct System, Model 7000 SeriesSummary page 2…vices: Ascent POCT System (K033480 and K073420) Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060) CerviFix@ System (K030377 and K01 1966) Technological neonTM possesses the same technological charac… | 2009 |
| * | K030377 | Modification to Synthes Cervifix SystemSummary page 2…) Nex-Link OCT and Cervicothoracic Spinal System (K031985, K052566, K062505 and K090060) CerviFix@ System (K030377 and K01 1966) Technological neonTM possesses the same technological characteristics as one or Characteristics: more of… | 2003 |
| * | K011969 | Synthes Cervifix System Our reading of the summary gave K011966, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CerviFix System”. | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230614 | Cortium™ | 2023 | 0 |
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 11 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 7 of the 90 ancestors have a recall of any class.
- Of its descendants, K230614 (Ulrich Medical USA, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K033980.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon m are indicated for the treatment of: * DDID (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), * spondylolisthesis, * spinal stenosis, *…
Read the full statement (151 words)
When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon m are indicated for the treatment of:
* DDID (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
* spondylolisthesis,
* spinal stenosis,
* fracture/dislocation,
* atlantoaxial fracture with instability,
* occipitocervical dislocation,
* revision of previous cervical spine surgery, and
* tumors
The cortical (3.5mm) bone screws are limited to occipital fixation only.
The.- hook, rod and crosslink component. placement is indicated for the cervical/upper thoracic (CI-T3) spine.
The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113346: Neon System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113346
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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