510(k) Report

510(k) · Cleared

Cleared

Pyrenees Cervical Plate System (Translational Plates)

K111135510(k) SpecialCleared Aug 17, 2011117-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 Aug 17, 2011 as substantially equivalent to K063544 (K2m, Inc., 2007) and 3 other predicates after a 117-day review. Its family tree reaches back 4 generations to 2003. 1 later device descends from it.

Decided
Aug 17, 2011
Review
117 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K031276 (2003). 15 ancestors in all, the oldest K926453 (1993). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2000: 3 other ancestors1997: 2 other ancestors2006: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor2015: 1 descendant clearedK031276 · 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 8 other ancestors 1 generation forward: 1 descendant K051665 · 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) · 20030
  1. Root · 4 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
  2. 3 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
  3. 2 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
  4. 1 generation backK051665 Synthes Vectra-T SystemSynthes Spine · 2005 · Recalled
  5. This deviceK111135 Pyrenees Cervical Plate System (Translational Plates)K2m, Inc. · 2011
  6. Descendant · cites it directly · 0 of its ownK142212 Pyrenees Cervical Plate SystemK2m, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K142212Pyrenees Cervical Plate SystemK2m, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199720
200030
200310
200510
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K111135, 2003–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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 1
…Q Device Class: 11 3. Predicate or legally marketed devices which are substantially equivalent * Pyrenees Cervical Plate System ( K2M, Inc. ) K063544 * Cervical Spine Locking Plate (Synthes) K971883, K000536 * Vectra-T (Synthes) K05 1665 4. Description of the de…
K2m, Inc.2007—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 1
…ally marketed devices which are substantially equivalent * Pyrenees Cervical Plate System ( K2M, Inc. ) K063544 * Cervical Spine Locking Plate (Synthes) K971883, K000536 * Vectra-T (Synthes) K05 1665 4. Description of the device: The Pyrenees Cervical Plate System is a sp…
Synthes (Usa)19971
*K000536Synthes Anterior CSLP System
Summary page 1
…eted devices which are substantially equivalent * Pyrenees Cervical Plate System ( K2M, Inc. ) K063544 * Cervical Spine Locking Plate (Synthes) K971883, K000536 * Vectra-T (Synthes) K05 1665 4. Description of the device: The Pyrenees Cervical Plate System is a spinal fixa…
Synthes Spine20001
*K051665Synthes Vectra-T System
Summary page 1
…equivalent * Pyrenees Cervical Plate System ( K2M, Inc. ) K063544 * Cervical Spine Locking Plate (Synthes) K971883, K000536 * Vectra-T (Synthes) K05 1665 4. Description of the device: The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical…
Synthes Spine20052

Also cleared against K063544: 7 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
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 8 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 4 of the 15 ancestors have a recall of any class.
  • Of its descendants, K142212 (K2m, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 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. 2011, 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 and 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), 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 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
  • K142212Pyrenees Cervical Plate SystemK2m, Inc. · 2015
  • K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012

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/K111135 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111135: Pyrenees Cervical Plate System (Translational Plates).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111135

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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