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, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 4, 2015 as substantially equivalent to K063544 (K2m, Inc., 2007) and 1 other predicate after a 45-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Sep 4, 2015
- Review
- 45 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K926453 (1993). 14 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 3 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- 2 generations backK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
- 1 generation backK150983 Pyrenees Cervical Plate SystemK2m · 2015
- This deviceK152015 Pyrenees Cervical Plate SystemK2m, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −3 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| −2 | K063544 | Modification to Pyrenees Cervical Plate System | K2m, Inc. | 2007 | — |
| −1 | K150983 | Pyrenees Cervical Plate System | K2m | 2015 | — |
| 0 (this device) | K152015 | Pyrenees Cervical Plate System | K2m, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K063544 | Modification to Pyrenees Cervical Plate SystemSummary page 4…n Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K150983) Device Description The Pyrenees Cervical Plate System con… | 2007 |
| * | K150983 | Pyrenees Cervical Plate SystemSummary page 4…060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K150983) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-startin… | 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 22 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 7 other devices also cite its predicate K063544.
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?
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152015: Pyrenees 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/K152015
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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