510(k) Report

510(k) · Cleared

Cleared

Pyrenees Cervical Plate System

K142212510(k) TraditionalCleared May 1, 2015262-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 May 1, 2015 as substantially equivalent to K063544 (K2m, Inc., 2007) and 4 other predicates after a 262-day review. Its family tree reaches back 5 generations to 2003.

Decided
May 1, 2015
Review
262 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K031276 (2003). 28 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2007: 2 other ancestors2004: 1 other ancestor2001: 1 other ancestor2006: 2 other ancestors2005: 1 other ancestor2003: 2 other ancestors2000: 5 other ancestors1999: 1 other ancestor1997: 2 other ancestors1992: 1 other ancestor1984: 1 other ancestor2002: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestorK031276 · Synthes Anterior Cervical Locking Plate (Aclp) System · Synthes (Usa) · 2003K033844 · Synthes Anterior Cervical Compression System · Synthes (Usa) · 2004K050451 · Synthes Vectra System · Synthes Spine Co.Lp · 2005 · recalledK051665 · Synthes Vectra-T System · Synthes Spine · 2005 · recalledK111135 · Pyrenees Cervical Plate System (Translational Plates) · K2m, Inc. · 20111980199020002010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 15 other ancestors3 generations back: 4 other ancestors K111135 · Pyrenees Cervical Plate System (Translational Plates) · K2m, Inc. · 2011K051665 · Synthes Vectra-T System · Synthes Spine · 2005 · recalledK050451 · Synthes Vectra System · Synthes Spine Co.Lp · 2005 · recalledK033844 · Synthes Anterior Cervical Compression System · Synthes (Usa) · 2004K031276 · Synthes Anterior Cervical Locking Plate (Aclp) System · Synthes (Usa) · 2003−50
  1. Root · 5 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
  2. 4 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
  3. 3 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
  4. 2 generations backK051665 Synthes Vectra-T SystemSynthes Spine · 2005 · Recalled
  5. 1 generation backK111135 Pyrenees Cervical Plate System (Translational Plates)K2m, Inc. · 2011
  6. This deviceK142212 Pyrenees Cervical Plate SystemK2m, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K031276Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa)2003—
−4K033844Synthes Anterior Cervical Compression SystemSynthes (Usa)2004—
−3K050451Synthes Vectra SystemSynthes Spine Co.Lp20053
−2K051665Synthes Vectra-T SystemSynthes Spine20052
−1K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.2011—
0 (this device)K142212Pyrenees Cervical Plate SystemK2m, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199210
199310
199510
199720
199910
200050
200110
200210
200320
200410
200510
200620
200720
201010
FIG. 1 — Lineage of K142212, 2003–2015Source: 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
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What was it cleared against? (5)

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
*K063544Modification to Pyrenees Cervical Plate System
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 (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K092474, K111135) DePuy Uniplate (K042544) Synthes CSLP (K003043) D…
K2m, Inc.2007—
*K092474Pyrenees Cervical Plate System, Semi-Constrained Screws
Summary page 4
….3060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K092474, K111135) DePuy Uniplate (K042544) Synthes CSLP (K003043) Device Description The Pyrenees Cervical Plate System consists of pla…
K2m, Inc.2010—
*K111135Pyrenees Cervical Plate System (Translational Plates)
Summary page 4
…oduct Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K092474, K111135) DePuy Uniplate (K042544) Synthes CSLP (K003043) Device Description The Pyrenees Cervical Plate System consists of plates (1-5…
K2m, Inc.2011—
*K042544Uniplate Anterior Cervical Plate System
Summary page 4
…te Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K092474, K111135) DePuy Uniplate (K042544) Synthes CSLP (K003043) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-t…
Depuy Spine, Inc.2004—
*K003043Surgical Titanium Mesh System
Summary page 4
…edicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K092474, K111135) DePuy Uniplate (K042544) Synthes CSLP (K003043) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-startin…
Depuyacromed2001—

Also cleared against K063544: 7 other devices →

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 12 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 6 of the 28 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K063544.

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K063544

7 other devices cite the same predicate.

  • K153526Pyrenees Cervical Plate SystemK2m · 2016
  • K152281Pyrenees Cervical Plate SystemK2m · 2015
  • K152015Pyrenees Cervical Plate SystemK2m, Inc. · 2015
  • K150983Pyrenees Cervical Plate SystemK2m · 2015
  • K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
  • K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc. · 2011

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

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/K142212 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142212: 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/K142212

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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