510(k) · Cleared
ClearedAzure Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 29, 2015 as substantially equivalent to K130825 (Orthofix, Inc., 2013) after a 220-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- May 29, 2015
- Review
- 220 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K922087 (1992). 44 ancestors in all, the oldest K831246 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations between
- 3 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 2 generations backK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
- 1 generation backK130825 Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2013 · Recalled
- This deviceK143028 Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 9 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 8 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 7 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- 6 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
- 5 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- 4 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 3 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 2 generations backK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
- 1 generation backK130825 Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2013 · Recalled
- This deviceK143028 Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −9 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −8 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −7 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| −6 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| −5 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| −4 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| −3 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| −2 | K121658 | Orthofix Acp (Anterior Cervical Plate System) | Orthofix, Inc. | 2012 | — |
| −1 | K130825 | Azure Anterior Cervical Plate System | Orthofix, Inc. | 2013 | 1 |
| 0 (this device) | K143028 | Azure Anterior Cervical Plate System | Orthofix, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K130825 | Azure Anterior Cervical Plate SystemSummary page 4…on, Spinal Intervertebral Body Regulatory Classification: Class II per 21 CFR § 888.3060 Review Panel: Orthopedic Device Panel Predicate Devices: K130825 – Azure Anterior Cervical Plate System, SE 5/7/2013 No reference devices we… | 2013 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 44 ancestors have a recall of any class.
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. 2015, 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 Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Trauma (i.e., fracture or dislocation);
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143028: Azure 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/K143028
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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