510(k) · Cleared
ClearedTectonic Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 17, 2005 after a 130-day review. The FDA summary names its predicate without a number. 39 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 130 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 1 citing it directly.
- This deviceK051531 Tectonic Cervical Plate SystemK2m, LLC · 2005
- Descendant · cites it directly · 38 of its ownK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
- Descendant · 2 generations on · 28 of its ownK113329 K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
- Descendant · 3 generations on · 21 of its ownK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013
- Descendant · 4 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · 5 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007 · cites it directly38descendants
- K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012 · 2 generations on28descendants
- K130202Iris Anterior Cervical PlateLife Spine, Inc. · 2013 · 3 generations on21descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 4 generations on18descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 5 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051531 | Tectonic Cervical Plate System | K2m, LLC | 2005 | — |
| +1 | K063544 | Modification to Pyrenees Cervical Plate System | K2m, Inc. | 2007 | — |
| +2 | K113329 | K2M, Pyrenees Cervical Plate System | K2m, Inc. | 2012 | — |
| +3 | K130202 | Iris Anterior Cervical Plate | Life Spine, Inc. | 2013 | — |
| +4 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +5 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | — | Cervical Spine Locking Plate System (Synthes) Named without a submission number | |
| * | — | Codman Anterior Cervical Plate System (Johnson & Johnson) Named without a submission number | |
| * | — | Blackstone Anterior Cervical Plate System (Blackstone Medical Inc.) Named without a submission number |
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063544 | Modification to Pyrenees Cervical Plate System | 2007 | 38 |
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, K063544 (K2m, Inc., 2007) has gone furthest, with 38 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.
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?
Indicated for use in anterior screw fixation to the cervical spine ( C2 - C7 ) for the following indications : degenerative disc disease ( DDD ), spondylolisthesis, trauma including fractures ), spinal stenosis and tumors ( primary and metastatic ), failed previous fusions (pseudarthrosis) and deformity ( defined as scoliosis, kyphosis or lordosis ).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051531: Tectonic 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/K051531
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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