510(k) · Cleared
ClearedNuvasive Helix Acp 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 Aug 8, 2007 after an 89-day review. The FDA summary names its predicate without a number. 103 later devices descend from it.
- Decided
- Aug 8, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
103 later devices descend from it, 3 citing it directly.
- This deviceK071329 Nuvasive Helix Acp SystemNuvasive, Inc. · 2007
- Descendant · cites it directly · 101 of its ownK122910 Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012
- Descendant · 2 generations on · 97 of its ownK131025 Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 94 of its ownK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- Descendant · 4 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · 5 generations on · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K122910Archon Anterior Cervical Plate Syste,Nu Vasive, Incorporated · 2012 · cites it directly101descendants
- K131025Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013 · 2 generations on97descendants
- K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016 · 3 generations on94descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 4 generations on83descendants
- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · 5 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071329 | Nuvasive Helix Acp System | Nuvasive, Inc. | 2007 | — |
| +1 | K122910 | Archon Anterior Cervical Plate Syste, | Nu Vasive, Incorporated | 2012 | — |
| +2 | K131025 | Archon Anterior Cervical Plate System | Nuvasive, Inc. | 2013 | — |
| +3 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| +4 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +5 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | — | Gradient Plus System Named without a submission number |
What descends from it? (103)
See all 1033 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?
- Of its descendants, K122910 (Nu Vasive, Incorporated, 2012) has gone furthest, with 101 descendants of its own.
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. 2007, 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 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…
Read the full statement (101 words)
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/K071329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071329: Nuvasive Helix Acp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071329
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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