510(k) Report

510(k) · Cleared

Cleared

Blue Mountain Cervical Plate

K112809510(k) TraditionalCleared Jun 20, 2012267-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

Qualgenix, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 20, 2012 as substantially equivalent to K000742 (Synthes Spine, 2000) and 11 other predicates after a 267-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.

Decided
Jun 20, 2012
Review
267 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
12

Its longest line of descent runs back 3 generations to K922087 (1992). 24 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors2000: 3 other ancestors1999: 3 other ancestors1998: 4 other ancestors1997: 3 other ancestors1995: 1 other ancestor1993: 2 other ancestors2015: 1 descendant cleared2017: 1 descendant clearedK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK000486 · Abc Cervical Plating System · Aesculap, Inc. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 7 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 19920
  1. Root · 3 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 2 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 1 generation backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. This deviceK112809 Blue Mountain Cervical PlateQualgenix, LLC · 2012
  5. Descendant · cites it directly · 1 of its ownK150036 Blue Mountain Cervical Plate SystemSpineway · 2015
  6. Descendant · 2 generations on · 0 of its ownK163602 Kepler I Cervical Plate SystemOrbbo Surgical, LLC · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K150036Blue Mountain Cervical Plate SystemSpineway · 2015 · cites it directly1descendant
  • K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−2K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−1K000486Abc Cervical Plating SystemAesculap, Inc.2000—
0 (this device)K112809Blue Mountain Cervical PlateQualgenix, LLC2012—
+1K150036Blue Mountain Cervical Plate SystemSpineway2015—
+2K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199510
199730
199840
199930
200030
200120
200310
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
FIG. 1 — Lineage of K112809, 1992–2017Source: 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? (12)

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
*K000742Synthes Anterior CSLP System
Summary page 2
…e Mountain Cervical Plate is substantially equivalent to the following predicate devices: Synthes Anterior CSLP System (K000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtroni…
Synthes Spine2000—
*K974706Aesculap Abc Cervical Plating System
Summary page 2
…lly equivalent to the following predicate devices: Synthes Anterior CSLP System (K000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K0422…
Aesculap, Inc.1998—
*K000486Abc Cervical Plating System
Summary page 2
…alent to the following predicate devices: Synthes Anterior CSLP System (K000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medt…
Aesculap, Inc.2000—
*K010466Tether Acfs
Summary page 2
…edicate devices: Synthes Anterior CSLP System (K000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir…
Theken Surgical,Llc2001—
*K982443Doc Ventral Cervical Stabilization System
Summary page 2
…hes Anterior CSLP System (K000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir (K0…
Depuy Motech Acromed1998—
*K042235Orion Anterior Cervical Plating System
Summary page 2
…000742); Aesculap ABC Cervical Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir (K030327, K994239); EBI Anterior Cervical Plate (1(0017…
Medtronic Sofamor Danek2004—
*K993855Atlantis Anterior Cervical Plate System
Summary page 2
…Plate (K974706, K000486); Theken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir (K030327, K994239); EBI Anterior Cervical Plate (1(001794);…
Danek Medical, Inc.1999—
*K030327Zephir Anterior Cervical System
Summary page 2
…heken Tether (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir (K030327, K994239); EBI Anterior Cervical Plate (1(001794); Spinevision C0 System (K012881); and X-Spine Spider C…
Medtronic Sofamor Danek2003—
*K994239Zephir Anterior Cervical Plate System
Summary page 2
…her (K010466); DePuy DOC (K982443); Medtronic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir (K030327, K994239); EBI Anterior Cervical Plate (1(001794); Spinevision C0 System (K012881); and X-Spine Spider Cervical…
Medtronic Sofamor Danek, Inc.2000—
*K001794Ebi Anterior Cervical Plate System
Summary page 2
…onic Orion (K042235); Medtronic Atlantis (K993855); Medtranic Zephir (K030327, K994239); EBI Anterior Cervical Plate (1(001794); Spinevision C0 System (K012881); and X-Spine Spider Cervical Plate (K052292).…
Ebi, L.P.2000—
*K012881C3 Anterior Cervical Plate System
Summary page 2
…Atlantis (K993855); Medtranic Zephir (K030327, K994239); EBI Anterior Cervical Plate (1(001794); Spinevision C0 System (K012881); and X-Spine Spider Cervical Plate (K052292). Performance Standards: Testing performed on this devic…
Spine Vision, Inc.2001—
*K052292Spider Cervical Plating (SCP) System
Summary page 2
…, K994239); EBI Anterior Cervical Plate (1(001794); Spinevision C0 System (K012881); and X-Spine Spider Cervical Plate (K052292). Performance Standards: Testing performed on this device indicates that the Qualgenix Blue Mountain…
X-Spine Systems, Inc.2005—

Also cleared against K000742: 15 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K150036Blue Mountain Cervical Plate SystemSpineway20151

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 20 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
  • 1 of the 24 ancestors has a recall of any class.
  • Of its descendants, K150036 (Spineway, 2015) has gone furthest, with 1 descendant of its own.
  • 15 other devices also cite its predicate K000742.

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. 2012, 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 Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies…

Read the full statement (124 words)

The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudloarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedlicles) of the cervical; thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Indications for use as stated in the FDA summary.

Also cleared against K000742

15 other devices cite the same predicate.

  • K240423TDM Anterior Cervical Plate SystemTdm Co., Ltd. · 2024
  • K190666CYGNUS™ Anterior Cervical Plate SystemMiRus, LLC · 2019
  • K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019
  • K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd. · 2017
  • K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda · 2016
  • K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation · 2015

More from Qualgenix, LLC

2 FDA decisions under this applicant name. See the company

  • K112696Twin Peaks Lumbar CageQualgenix, LLC · 2012

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/K112809 · printed Nov 3, 2026

Cite this page

510(k) Report. “K112809: Blue Mountain Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112809

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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