510(k) Report

510(k) · Cleared

Cleared

Pyrenees Cervical Plate System

K150983510(k) TraditionalCleared Jul 14, 201591-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 Jul 14, 2015 as substantially equivalent to K063544 (K2m, Inc., 2007) and 5 other predicates after a 91-day review. Its family tree reaches back 3 generations to 1993. 7 later devices descend from it.

Decided
Jul 14, 2015
Review
91 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K926453 (1993). 13 ancestors in all, the oldest K914362 (1992). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2004: 1 other ancestor2000: 3 other ancestors1997: 1 other ancestor2005: 1 other ancestor1995: 1 other ancestor1992: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 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. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants K063544 · 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 · 3 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. 2 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
  3. 1 generation backK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
  4. This deviceK150983 Pyrenees Cervical Plate SystemK2m · 2015
  5. Descendant · cites it directly · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
  6. Descendant · 2 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
  7. Descendant · 3 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
  8. Descendant · 3 generations on · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
  9. Descendant · 4 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12018: 12022: 12023: 12024: 12026: 1
2015high 1 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all
  • K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 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 · 3 generations on1descendant
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · 3 generations on1descendant
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
−2K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa)19971
−1K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.2007—
0 (this device)K150983Pyrenees Cervical Plate SystemK2m2015—
+1K162664Pyrenees Cervical Plate SystemK2m, Inc.2016—
+2K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™…Stryker Corporation2022—
+4K253545Vulcan Spinal SystemK2m, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
199710
200030
200410
200510
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201810
202210
202310
202410
202610
FIG. 1 — Lineage of K150983, 1993–2026Source: 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? (6)

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: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730) Devic…
K2m, Inc.2007—
*K042544Uniplate Anterior Cervical Plate System
Summary page 4
…Orthosis (21 CFR 888.3060, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730) Device Description The Pyrenees Cervical Plate System…
Depuy Spine, Inc.2004—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 4
…60, Product Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730) Device Description The Pyrenees Cervical Plate System consists of plates (1-…
Synthes (Usa)19971
*K000536Synthes Anterior CSLP System
Summary page 4
…ct Code KWQ) Predicate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 level)…
Synthes Spine20001
*K060379Ebi Anterior Cervical Plate System
Summary page 4
…ate Device(s) Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapp…
Ebi, L.P.2006—
*K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate System
Summary page 4
…Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730) Device Description The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-starting…
Depuy, Inc.1997—

Also cleared against K063544: 7 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K162664Pyrenees Cervical Plate SystemK2m, Inc.20165
K152015Pyrenees 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 22 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
  • 2 of the 13 ancestors have a recall of any class.
  • Of its descendants, K162664 (K2m, Inc., 2016) has gone furthest, with 5 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. 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 K063544

7 other devices cite the same predicate.

  • K153526Pyrenees Cervical Plate SystemK2m · 2016
  • K152281Pyrenees Cervical Plate SystemK2m · 2015
  • K152015Pyrenees Cervical Plate SystemK2m, Inc. · 2015
  • K142212Pyrenees Cervical Plate SystemK2m, Inc. · 2015
  • K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
  • K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc. · 2011

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/K150983 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150983: 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/K150983

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