510(k) Report

510(k) · Cleared

Cleared

Modification to Pyrenees Cervical Plate System

K063544510(k) SpecialCleared Feb 14, 200782-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Feb 14, 2007 as substantially equivalent to K060442 (K2m, LLC, 2006) and 5 other predicates after an 82-day review. Its family tree reaches back 2 generations to 1993. 38 later devices descend from it.

Decided
Feb 14, 2007
Review
82 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K926453 (1993). 8 ancestors in all. 38 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2000: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor2015: 5 descendants cleared2016: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2013: 1 descendant cleared2023: 6 descendants cleared2017: 2 descendants cleared2024: 6 descendants cleared2022: 2 descendants cleared2026: 3 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2025: 3 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalledK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5
  1. Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 1 generation backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
  3. This deviceK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
  4. Descendant · cites it directly · 28 of its ownK113329 K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
  5. Descendant · 2 generations on · 21 of its ownK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013
  6. Descendant · 3 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  7. Descendant · 4 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
  8. Descendant · 5 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 12013: 12015: 52016: 22017: 22018: 12019: 12020: 22021: 12022: 22023: 62024: 62025: 32026: 3
2010high 6 (2023) · low 0 (2014)2026

Most influential descendants

Showing 5 of 38 · See all
  • K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012 · cites it directly28descendants
  • K130202Iris Anterior Cervical PlateLife Spine, Inc. · 2013 · 2 generations on21descendants
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 3 generations on18descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 4 generations on15descendants
  • K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−1K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19971
0 (this device)K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.2007—
+1K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.2012—
+2K130202Iris Anterior Cervical PlateLife Spine, Inc.2013—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+4K190016Lateral Plate SystemCorelink, LLC2019—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
200020
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
201310
201550
201620
201720
201810
201910
202020
202110
202220
202360
202460
202530
202630
FIG. 1 — Lineage of K063544, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K060442Pyrenees Cervical Plate System
Summary page 1
…performed and demonstrated that the modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cerv…
K2m, LLC2006—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 1
…ed that the modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K9717…
Synthes (Usa)19971
*K000538Mallory/Head Lateralized Press-Fit Femoral
Summary page 1
…he modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K9264…
Biomet, Inc.2000—
*K051531Tectonic Cervical Plate System
Summary page 1
…quivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K…
K2m, LLC2005—
*K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate System
Summary page 1
…Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592). 6. Comparison of the technological characte…
Depuy, Inc.1997—
Kept off the family treeK926486De Puy Acromed PEAK Cervical Plate System
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…ate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592). 6. Comparison of the technological characteristics o…
*K002592Interpore Cross Anterior Cervical Plate System
Summary page 1
…r Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592). 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices: There…
Interpore Cross Intl.2000—

Also cleared against K060442: 1 other device →

What descends from it? (38)

See all 38

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228
K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108
K150983Pyrenees Cervical Plate SystemK2m20157
K153526Pyrenees Cervical Plate SystemK2m20166
K152281Pyrenees Cervical Plate SystemK2m20156
K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111
K152015Pyrenees Cervical Plate SystemK2m, Inc.20150
K142212Pyrenees Cervical Plate SystemK2m, Inc.20150

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 14 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K113329 (K2m, Inc., 2012) has gone furthest, with 28 descendants of its own.
  • 1 other device also cites its predicate K060442.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The Pyrenees Cervical Plate System is 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.

Also cleared against K060442

1 other device cites the same predicate.

  • K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine · 2021

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Recent decisions in KWQ

The KWQ category page

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https://510kreport.com/device/K063544 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063544: Modification to 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/K063544

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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