510(k) · Cleared
ClearedCuriteva Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curiteva, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 2, 2018 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 1 other predicate after a 49-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 2, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000536 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
- 4 generations backK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
- 3 generations backK083562 Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
- 2 generations backK142237 Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015
- 1 generation backK150759 Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015
- This deviceK181562 Curiteva Anterior Cervical Plate SystemCuriteva, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000536 | Synthes Anterior CSLP System | Synthes Spine | 2000 | 1 |
| −4 | K062310 | Reflex Hybrid Acp System | Stryker Spine | 2006 | 2 |
| −3 | K083562 | Stryker Spine Nulock Anterior Cervical Plating System | Stryker Corp. | 2009 | — |
| −2 | K142237 | Aviator Anterior Cervical Plate (ACP) System | Stryker Corporation | 2015 | — |
| −1 | K150759 | Hyper-C Anterior Cervical Plate System | Degen Medical | 2015 | — |
| 0 (this device) | K181562 | Curiteva Anterior Cervical Plate System | Curiteva, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 4…t Devices e Predicate Device(s): Primary: Synthes pAnterior CSLP System – K030866 s Additional: DeGen Medical Hyper-C Anter… | 2003 |
| * | K150759 | Hyper-C Anterior Cervical Plate SystemSummary page 4…s Additional: DeGen Medical Hyper-C Anterior Cervical Plate System -- K150759 C. Device Description The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available i… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 41 other devices also cite its predicate K030866.
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. 2018, 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 Curiteva Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181562: Curiteva 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/K181562
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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