510(k) Report

510(k) · Cleared

Cleared

Custom Spine Regent Anterior Cervical Plate

K091134510(k) TraditionalCleared Aug 17, 2009119-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

Custom Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 17, 2009 as substantially equivalent to K041469 (X-Spine Systems, 2004) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 2003. 10 later devices descend from it.

Decided
Aug 17, 2009
Review
119 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K030866 (2003). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2014: 1 descendant cleared2010: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2026: 1 descendant clearedK030866 · Synthes Anterior CSLP System · Synthes (Usa) · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K030866 · Synthes Anterior CSLP System · Synthes (Usa) · 20030+5
  1. Root · 1 generation backK030866 Synthes Anterior CSLP SystemSynthes (Usa) · 2003
  2. This deviceK091134 Custom Spine Regent Anterior Cervical PlateCustom Spine, Inc. · 2009
  3. Descendant · cites it directly · 8 of its ownK141993 Nakoma AcpAlliance Partners, LLC · 2014 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
  5. Descendant · 3 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
  6. Descendant · 2 generations on · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018
  7. Descendant · 4 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2010: 12014: 12018: 12020: 12021: 12023: 12024: 12025: 22026: 1
2010high 2 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 10 · See all
  • K141993Nakoma AcpAlliance Partners, LLC · 2014 · cites it directly8descendants
  • K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 2 generations on3descendants
  • K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 3 generations on2descendants
  • K173128Alamo® CAlliance Partners, LLC · 2018 · 2 generations on2descendants
  • K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K030866Synthes Anterior CSLP SystemSynthes (Usa)2003—
0 (this device)K091134Custom Spine Regent Anterior Cervical PlateCustom Spine, Inc.2009—
+1K141993Nakoma AcpAlliance Partners, LLC20141
+2K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2023—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.2024—
+2K173128Alamo® CAlliance Partners, LLC2018—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201410
201810
202010
202110
202310
202410
202520
202610
FIG. 1 — Lineage of K091134, 2003–2026Source: 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? (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
*K041469Anterior Compact System
Summary page 1
…ixation Orthosis. Device Classification: Class 11 Regulation Number: 21 CFR 888.3060 Device Product Codes: KWQ Predicate Devices X-Spine Anterior Compact Plate System (K041469), Synthes CSLP (K030866) Device Desc~ription The REGENT Anterior Cervical Plate System is composed of various cervical…
X-Spine Systems2004—
*K030866Synthes Anterior CSLP System
Summary page 1
…Classification: Class 11 Regulation Number: 21 CFR 888.3060 Device Product Codes: KWQ Predicate Devices X-Spine Anterior Compact Plate System (K041469), Synthes CSLP (K030866) Device Desc~ription The REGENT Anterior Cervical Plate System is composed of various cervical…
Synthes (Usa)2003—

Also cleared against K041469: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K141993Nakoma AcpAlliance Partners, LLC20148
K101151Regent Anterior Cervical PlateCustom Spine20100

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K141993 (Alliance Partners, LLC, 2014) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K041469.

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. 2009, 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 REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: * Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) *…

Read the full statement (124 words)

The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

* Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

* Trauma (including fractures).

* Tumors

Deformities or curvatures (including kyphosis, lordosis or scoliosis)

* Pseudoarthrosis

* Failed previous fusion

Spondylolisthesis

Spinal Stenosis

THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.

WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Indications for use as stated in the FDA summary.

Also cleared against K041469

2 other devices cite the same predicate.

  • K100265Diamond Anterior Cervical Plate SystemAmendia, Inc. · 2010
  • K072650Ist Anterior Cervical Plate SystemInnovative Spinal Technologies, Inc. · 2007

More from Custom Spine, Inc.

12 FDA decisions under this applicant name. See the company

  • K143143Pathway ElifCustom Spine, Inc. · 2015
  • K132596Proposed OptimusCustom Spine, Inc. · 20141 recall
  • K120597KompredaCustom Spine, Inc. · 2013
  • K111726Pathway AvidCustom Spine, Inc. · 2012
  • K111099Issys LP Spinal Fixation SystemCustom Spine, Inc. · 20111 recall

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/K091134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091134: Custom Spine Regent Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091134

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