510(k) · Cleared
ClearedPyrenees 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 May 15, 2006 after an 83-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.
- Decided
- May 15, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 2 citing it directly.
- This deviceK060442 Pyrenees Cervical Plate SystemK2m, LLC · 2006
- 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 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · 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) | K060442 | Pyrenees Cervical Plate System | K2m, LLC | 2006 | — |
| +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 | 2 | 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 Named without a submission number | |
| * | — | Tectonic Cervical Plate System Named without a submission number | |
| * | — | PEAK Anterior Cervical Plate System Named without a submission number |
What descends from it? (40)
See all 402 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, 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/K060442 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060442: Pyrenees Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060442
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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