510(k) · Cleared
ClearedArchon Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 27, 2013 as substantially equivalent to K122910 (Nu Vasive, Incorporated, 2012) and 4 other predicates after a 229-day review. Its family tree reaches back 4 generations to 1992. 97 later devices descend from it.
- Decided
- Nov 27, 2013
- Review
- 229 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K922087 (1992). 17 ancestors in all. 97 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 3 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 2 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 1 generation backK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
- This deviceK131025 Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · 3 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- Descendant · 3 generations on · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · cites it directly94descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 2 generations on83descendants
- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 3 generations on37descendants
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · 3 generations on36descendants
- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −3 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −2 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −1 | K122910 | Archon Anterior Cervical Plate Syste, | Nu Vasive, Incorporated | 2012 | — |
| 0 (this device) | K131025 | Archon Anterior Cervical Plate System | Nuvasive, Inc. | 2013 | — |
| +1 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +3 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| +3 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +3 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 17 | 0 |
| 2025 | 24 | 0 |
| 2026 | 17 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K122910 | Archon Anterior Cervical Plate Syste,Summary page 2…ture review, were used to demonstrate that the subject Archion Anterior Cervical Plate £vstem is substantially equivalent to Archion Anterior Cervical Plate System (K 122910). The addition of the Archion Anterior Cervical Plate System wide plate configuration does not present a new worst-case… | 2012 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 1…erior Cervical Plate System is substantially equivalent to the following devices: " KI 22910 - Nit Vasive®&Archion Anterior Cervical Plate System * K000536 - Synthes Spine Anterior CSLP System * K02 1461 - Medironic Atlantis Anterior Cervical Plate System * KO 10003 -… | 2000 |
| * | K021461 | Atlantis Vision Anterior Cervical Plate SystemSummary page 1…to the following devices: " KI 22910 - Nit Vasive®&Archion Anterior Cervical Plate System * K000536 - Synthes Spine Anterior CSLP System * K02 1461 - Medironic Atlantis Anterior Cervical Plate System * KO 10003 - Biomet EBI Vuelocc Anterior Cervical Plate System… | 2002 |
| * | K010003 | Ebi Vuelock Anterior Cervical Plate System | 2001 |
| * | K053581 | Nuvasive Smartplate Gradient Plus SystemSummary page 1…erior CSLP System * K02 1461 - Medironic Atlantis Anterior Cervical Plate System * KO 10003 - Biomet EBI Vuelocc Anterior Cervical Plate System " K053581 - NitVasive SmartPlate Gradient Plus System D. Device Description The NuVasive Archion Anterior Cervical Plate System i… | 2006 |
What descends from it? (97)
See all 973 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 21 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K161442 (Nu Vasive, Incorporated, 2016) has gone furthest, with 94 descendants of its own.
- 2 other devices also cite its predicate K122910.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis…
Read the full statement (135 words)
The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
Indications for the use of the implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hole version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomnies for the treatment of tumors and burst fractures.
WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131025: Archon Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131025
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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