510(k) · Cleared
ClearedNuVasive Anterior Cervical Plate Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 3, 2021 as substantially equivalent to K071329 (Nuvasive, Inc., 2007) and 7 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Nov 3, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K922087 (1992). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 5 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 4 generations backK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
- 3 generations backK191500 NuVasive® ACP SystemNu Vasive, Incorporated · 2019
- 2 generations backK201078 NuVasive® ACP SystemNu Vasive, Incorporated · 2020
- 1 generation backK203253 NuVasive ACP SystemNu Vasive, Incorporated · 2020
- This deviceK212446 NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated · 2021
- Descendant · cites it directly · 0 of its ownK251965 Proximity Anterior Cervical Plate System; Segmental Plating System…Alphatec Spine, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −6 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −5 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −4 | K122910 | Archon Anterior Cervical Plate Syste, | Nu Vasive, Incorporated | 2012 | — |
| −3 | K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | 2019 | — |
| −2 | K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | 2020 | — |
| −1 | K203253 | NuVasive ACP System | Nu Vasive, Incorporated | 2020 | — |
| 0 (this device) | K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | 2021 | — |
| +1 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025 | — |
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 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K071329 | Nuvasive Helix Acp SystemSummary page 7…Predicate Devices The subject NuVasive Anterior Cervical Plate Systems are substantially equivalent to the following devices: Primary Predicate • K071329 – NuVasive Helix ACP System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K083341 – NuVas… | 2007 |
| * | K073275 | Nuvasive Helix Mini Acp SystemSummary page 7…tems are substantially equivalent to the following devices: Primary Predicate • K071329 – NuVasive Helix ACP System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K083341 – NuVasive Helix-T Anterior Cervical Plate System • K093804 – NuVasive H… | 2008 |
| * | K083341 | Nuvasive Helix-T Acp SystemSummary page 7…owing devices: Primary Predicate • K071329 – NuVasive Helix ACP System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K083341 – NuVasive Helix-T Anterior Cervical Plate System • K093804 – NuVasive Helix Revolution ACP System • K203253 – NuVa… | 2009 |
| * | K093804 | Nuvasive Helix Revolution Acp SystemSummary page 7…Helix ACP System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K083341 – NuVasive Helix-T Anterior Cervical Plate System • K093804 – NuVasive Helix Revolution ACP System • K203253 – NuVasive ACP System • K122910 – NuVasive Archon Anterior Cervica… | 2010 |
| * | K203253 | NuVasive ACP SystemSummary page 7…3275 – NuVasive Helix Mini ACP System • K083341 – NuVasive Helix-T Anterior Cervical Plate System • K093804 – NuVasive Helix Revolution ACP System • K203253 – NuVasive ACP System • K122910 – NuVasive Archon Anterior Cervical Plate System • K131025 – NuVasive Archon Anteri… | 2020 |
| * | K122910 | Archon Anterior Cervical Plate Syste,Summary page 7…• K083341 – NuVasive Helix-T Anterior Cervical Plate System • K093804 – NuVasive Helix Revolution ACP System • K203253 – NuVasive ACP System • K122910 – NuVasive Archon Anterior Cervical Plate System • K131025 – NuVasive Archon Anterior Cervical Plate System • K0535… | 2012 |
| * | K131025 | Archon Anterior Cervical Plate SystemSummary page 7…• K093804 – NuVasive Helix Revolution ACP System • K203253 – NuVasive ACP System • K122910 – NuVasive Archon Anterior Cervical Plate System • K131025 – NuVasive Archon Anterior Cervical Plate System • K053581 – NuVasive SmartPlate Gradient Plus System D. Device Descrip… | 2013 |
| * | K053581 | Nuvasive Smartplate Gradient Plus SystemSummary page 7…203253 – NuVasive ACP System • K122910 – NuVasive Archon Anterior Cervical Plate System • K131025 – NuVasive Archon Anterior Cervical Plate System • K053581 – NuVasive SmartPlate Gradient Plus System D. Device Description The NuVasive Anterior Cervical Plate Systems are anterio… | 2006 |
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 |
|---|---|---|---|
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | 2025 | 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 29 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K251965 (Alphatec Spine, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071329.
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. 2021, 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® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.…
Read the full statement (396 words)
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
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-hale version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies 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.
The NuVasive SmartPlate Gradient Plus 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 this 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.
WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The NuVasive HELIX Anterior Cervical Plating 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 this 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.
WARNING: The NuVasive HELIX Anterior Cervical Plating 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/K212446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212446: NuVasive Anterior Cervical Plate Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212446
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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