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 Oct 7, 2016 as substantially equivalent to K150983 (K2m, 2015) and 2 other predicates after an 11-day review. Its family tree reaches back 6 generations to 2000. 5 later devices descend from it.
- Decided
- Oct 7, 2016
- Review
- 11 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K002592 (2000). 37 ancestors in all, the oldest K914362 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
- 5 generations backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
- 4 generations backK062831 Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine · 2006
- 3 generations backK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
- 2 generations backK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
- 1 generation backK153526 Pyrenees Cervical Plate SystemK2m · 2016
- This deviceK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 2 generations on · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · cites it directly4descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
- K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · 2 generations on1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 3 generations on0descendants
- K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | 2000 | — |
| −5 | K040844 | Life Spine Neo Anterior Cervical Plate System | Life Spine, LLC | 2004 | — |
| −4 | K062831 | Modification to Life Spine Neo Anterior Cervical Plate System | Life Spine | 2006 | — |
| −3 | K093776 | Indus Anterior Cervical Plate System | Spinefrontier, Inc. | 2010 | — |
| −2 | K121060 | Spine Frontier Indus Acp System | Spinefrontier, Inc. | 2012 | 6 |
| −1 | K153526 | Pyrenees Cervical Plate System | K2m | 2016 | — |
| 0 (this device) | K162664 | Pyrenees Cervical Plate System | K2m, Inc. | 2016 | — |
| +1 | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK… | K2m, Inc. | 2018 | — |
| +2 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +2 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
| +3 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
| +3 | K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical… | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K150983 | Pyrenees Cervical Plate SystemSummary page 4…on Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K150983) Additional Predicates: K2M Pyrenees Cervical Plate System (K153526) DePuy Uniplate (K042544) Device Description The Pyrenees C… | 2015 |
| * | K153526 | Pyrenees Cervical Plate SystemSummary page 4….3060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K150983) Additional Predicates: K2M Pyrenees Cervical Plate System (K153526) DePuy Uniplate (K042544) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 levels) and screws (sel… | 2016 |
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 4…Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K150983) Additional Predicates: K2M Pyrenees Cervical Plate System (K153526) DePuy Uniplate (K042544) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 levels) and screws (self-tapping and self-starti… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate… | 2018 | 4 |
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 16 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 37 ancestors have a recall of any class.
- Of its descendants, K182473 (K2m, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K150983.
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. 2016, 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?
PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) 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/K162664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162664: 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/K162664
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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