510(k) Report

510(k) · Cleared

Cleared

Pyrenees Cervical Plate System

K152281510(k) SpecialCleared Sep 24, 201543-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 · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 24, 2015 as substantially equivalent to K092474 (K2m, Inc., 2010) and 1 other predicate after a 43-day review. Its family tree reaches back 4 generations to 1993. 6 later devices descend from it.

Decided
Sep 24, 2015
Review
43 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K926453 (1993). 17 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2005: 1 other ancestor2003: 1 other ancestor2000: 5 other ancestors1997: 1 other ancestor2002: 1 other ancestor1995: 1 other ancestor2017: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 1993K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalledK063544 · Modification to Pyrenees Cervical Plate System · K2m, Inc. · 2007K092474 · Pyrenees Cervical Plate System, Semi-Constrained Screws · K2m, Inc. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 11 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K092474 · Pyrenees Cervical Plate System, Semi-Constrained Screws · K2m, Inc. · 2010K063544 · Modification to Pyrenees Cervical Plate System · K2m, Inc. · 2007K971883 · Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System · Synthes (Usa) · 1997 · recalledK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930
  1. Root · 4 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 3 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
  3. 2 generations backK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
  4. 1 generation backK092474 Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc. · 2010
  5. This deviceK152281 Pyrenees Cervical Plate SystemK2m · 2015
  6. Descendant · cites it directly · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
  7. Descendant · 2 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
  8. Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
  9. Descendant · 3 generations on · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
  10. Descendant · 3 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12022: 12023: 12024: 12026: 1
2017high 1 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · cites it directly5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 2 generations on4descendants
  • 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 · 3 generations on1descendant
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−3K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19971
−2K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.2007—
−1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.2010—
0 (this device)K152281Pyrenees Cervical Plate SystemK2m2015—
+1K172104Ozark (tm) Cervical Plate SystemK2m, Inc.2017—
+2K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™…Stryker Corporation2022—
+3K253545Vulcan Spinal SystemK2m, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
200050
200210
200310
200510
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202210
202310
202410
202610
FIG. 1 — Lineage of K152281, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K092474Pyrenees Cervical Plate System, Semi-Constrained Screws
Summary 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 (K092474) Additional Predicates: K2M Pyrenees Cervical Plate System (K063544) Device Description The Pyrenees Cervical Plate System consi…
K2m, Inc.2010—
*K063544Modification to Pyrenees Cervical Plate System
Summary page 4
….3060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K092474) Additional Predicates: K2M Pyrenees Cervical Plate System (K063544) Device Description The Pyrenees Cervical Plate System consists of plates and screws made of titanium alloy (Ti- 6Al-4V per ASTM…
K2m, Inc.2007—

Also cleared against K092474: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175

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 5.5 years on median.
  • 4 of the 17 ancestors have a recall of any class.
  • Of its descendants, K172104 (K2m, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K092474.

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. 2015, 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?

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 as stated in the FDA summary.

Also cleared against K092474

1 other device cites the same predicate.

  • K142212Pyrenees Cervical Plate SystemK2m, Inc. · 2015

More from K2m

16 FDA decisions under this applicant name. See the company

  • K182182YUKON OCT Spinal SystemK2m · 2018
  • K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
  • K172941CASCADIA Interbody SystemK2m · 2018
  • K171556K2M Navigation InstrumentsK2m · 2018
  • K173508Everest Spinal SystemK2m · 2018

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K152281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152281: 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/K152281

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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