510(k) · Cleared
ClearedNuVasive® ACP System
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 May 20, 2020 as substantially equivalent to K191500 (Nu Vasive, Incorporated, 2019) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it.
- Decided
- May 20, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922087 (1992). 18 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 4 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 3 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 2 generations backK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
- 1 generation backK191500 NuVasive® ACP SystemNu Vasive, Incorporated · 2019
- This deviceK201078 NuVasive® ACP SystemNu Vasive, Incorporated · 2020
- Descendant · cites it directly · 2 of its ownK203253 NuVasive ACP SystemNu Vasive, Incorporated · 2020
- Descendant · 2 generations on · 1 of its ownK212446 NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated · 2021
- Descendant · 3 generations on · 0 of its ownK251965 Proximity Anterior Cervical Plate System; Segmental Plating System…Alphatec Spine, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K203253NuVasive ACP SystemNu Vasive, Incorporated · 2020 · cites it directly2descendants
- K212446NuVasive Anterior Cervical Plate SystemsNu Vasive, Incorporated · 2021 · 2 generations on1descendant
- K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −4 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −3 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −2 | K122910 | Archon Anterior Cervical Plate Syste, | Nu Vasive, Incorporated | 2012 | — |
| −1 | K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | 2019 | — |
| 0 (this device) | K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | 2020 | — |
| +1 | K203253 | NuVasive ACP System | Nu Vasive, Incorporated | 2020 | — |
| +2 | K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | 2021 | — |
| +3 | 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 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K191500 | NuVasive® ACP SystemSummary page 4…KWQ C. Predicate Devices The subject NuVasive ACP System is substantially equivalent to the following devices: Primary Predicate x K191500 – NuVasive® ACP System Additional Predicates x K073275 – NuVasive Helix Mini ACP System D. Device Description… | 2019 |
| * | K073275 | Nuvasive Helix Mini Acp SystemSummary page 4…sive ACP System is substantially equivalent to the following devices: Primary Predicate x K191500 – NuVasive® ACP System Additional Predicates x K073275 – NuVasive Helix Mini ACP System D. Device Description The NuVasive ACP System is an anterior cervical plating system tha… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203253 | NuVasive ACP System | 2020 | 2 |
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 28 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K203253 (Nu Vasive, Incorporated, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K191500.
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. 2020, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201078: NuVasive® ACP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201078
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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