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 Sep 3, 2019 as substantially equivalent to K122910 (Nu Vasive, Incorporated, 2012) and 3 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 3, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K922087 (1992). 17 ancestors in all. 4 later devices descend from it, 2 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 deviceK191500 NuVasive® ACP SystemNu Vasive, Incorporated · 2019
- Descendant · cites it directly · 3 of its ownK201078 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 4 of 4 · See all- K201078NuVasive® ACP SystemNu Vasive, Incorporated · 2020 · cites it directly3descendants
- 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 |
|---|---|---|---|---|---|
| −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) | K191500 | NuVasive® ACP System | Nu Vasive, Incorporated | 2019 | — |
| +1 | 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 | 2 | 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? (4)
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 4…KWQ C. Predicate Devices The subject NuVasive ACP System is substantially equivalent to the following devices: Primary Predicate • K122910 – NuVasive Archon Anterior Cervical Plate System Additional Predicates • K073275 – NuVasive Helix Mini ACP System… | 2012 |
| * | K073275 | Nuvasive Helix Mini Acp SystemSummary page 4…tially equivalent to the following devices: Primary Predicate • K122910 – NuVasive Archon Anterior Cervical Plate System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K023133 – EBI VueLock Anterior Cervical Plate System • K030866 – Synthes Anterio… | 2008 |
| * | K023133 | Modification to Ebi Vuelock Anterior Cervical Plate SystemSummary page 4…Primary Predicate • K122910 – NuVasive Archon Anterior Cervical Plate System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K023133 – EBI VueLock Anterior Cervical Plate System • K030866 – Synthes Anterior CSLP System Reference Predicate • K1… | 2002 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 4…Cervical Plate System Additional Predicates • K073275 – NuVasive Helix Mini ACP System • K023133 – EBI VueLock Anterior Cervical Plate System • K030866 – Synthes Anterior CSLP System Reference Predicate • K180198 – NuVasive VuePoint II OCT System D. Device Descript… | 2003 |
| † | K180198 | NuVasive® VuePoint® II OCT System | 2018 |
What descends from it? (4)
2 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 27 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K201078 (Nu Vasive, Incorporated, 2020) has gone furthest, with 3 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. 2019, 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/K191500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191500: NuVasive® ACP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191500
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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