510(k) Report

510(k) · Cleared

Cleared

Hedgehog Cervical Interbody Fusion Device

K143685510(k) TraditionalCleared Sep 23, 2015273-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vertera, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Sep 23, 2015 as substantially equivalent to K133218 (Spinal Elements, Inc., 2014) after a 273-day review. Its family tree reaches back 4 generations to 2008. 23 later devices descend from it.

Decided
Sep 23, 2015
Review
273 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K072991 (2008). 9 ancestors in all, the oldest P980048 (2001). 23 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2008: 1 other ancestor2007: 1 other ancestor2009: 1 other ancestor2001: 1 other ancestor2017: 1 descendant cleared2022: 2 descendants cleared2023: 4 descendants cleared2025: 8 descendants cleared2024: 3 descendants cleared2026: 5 descendants clearedK072991 · Patriot Spacers: Colonial Acdf · Globus Medical, Inc. · 2008K083389 · Coalition Spacer · Globus Medical, Inc. · 2009K122771 · Spinal Elements Cervical Intervertebral Body Fusion System · Spinal Elements, Inc. · 2013K133218 · Crystal ®; Mosaic ®; Vertu ® · Spinal Elements, Inc. · 2014200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 8 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants K133218 · Crystal ®; Mosaic ®; Vertu ® · Spinal Elements, Inc. · 2014K122771 · Spinal Elements Cervical Intervertebral Body Fusion System · Spinal Elements, Inc. · 2013K083389 · Coalition Spacer · Globus Medical, Inc. · 2009K072991 · Patriot Spacers: Colonial Acdf · Globus Medical, Inc. · 20080+5
  1. Root · 4 generations backK072991 Patriot Spacers: Colonial AcdfGlobus Medical, Inc. · 2008
  2. 3 generations backK083389 Coalition SpacerGlobus Medical, Inc. · 2009
  3. 2 generations backK122771 Spinal Elements Cervical Intervertebral Body Fusion SystemSpinal Elements, Inc. · 2013
  4. 1 generation backK133218 Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc. · 2014
  5. This deviceK143685 Hedgehog Cervical Interbody Fusion DeviceVertera, Inc. · 2015
  6. Descendant · cites it directly · 22 of its ownK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
  7. Descendant · 2 generations on · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
  8. Descendant · 2 generations on · 6 of its ownK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
  9. Descendant · 3 generations on · 4 of its ownK232150 ZSFab Cervical Interbody SystemZsfab, Inc. · 2023
  10. Descendant · 2 generations on · 4 of its ownK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2017: 12022: 22023: 42024: 32025: 82026: 5
2017high 8 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 23 · See all
  • K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017 · cites it directly22descendants
  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · 2 generations on9descendants
  • K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023 · 2 generations on6descendants
  • K232150ZSFab Cervical Interbody SystemZsfab, Inc. · 2023 · 3 generations on4descendants
  • K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K072991Patriot Spacers: Colonial AcdfGlobus Medical, Inc.2008—
−3K083389Coalition SpacerGlobus Medical, Inc.2009—
−2K122771Spinal Elements Cervical Intervertebral Body Fusion SystemSpinal Elements, Inc.2013—
−1K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.2014—
0 (this device)K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.2015—
+1K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated2017—
+2K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured…Nu Vasive, Incorporated2023—
+2K222004INTEGRATE -C Interbody Fusion SystemHappe Spine2023—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.2023—
+2K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200710
200810
200910
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202220
202340
202430
202580
202650
FIG. 1 — Lineage of K143685, 2008–2026Source: 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 ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (1)

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
*K133218Crystal ®; Mosaic ®; Vertu ®
Summary page 4
…tebral Body Fusion Device, 888.3080 E. Product Code: ODP, Intervertebral Body Fusion Device, Cervical F. Predicate Device(s): Spinal Elements, Crystal®, K133218 G. Physical Description: The proposed Hedgehog Cervical Interbody Fusion Device is a sterile, single use…
Spinal Elements, Inc.2014—

Also cleared against K133218: 5 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722

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 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K173030 (Nu Vasive, Incorporated, 2017) has gone furthest, with 22 descendants of its own.
  • 5 other devices also cite its predicate K133218.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K133218

5 other devices cite the same predicate.

  • K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
  • K192906Mecta-C Stand AloneMedacta International S.A. · 2020
  • K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
  • K181621Stable-C Interbody SystemNexus Spine, LLC · 2018
  • K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018

More from Vertera, Inc.

2 FDA decisions under this applicant name. See the company

  • K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion SystemVertera, Inc. · 2017

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K143685 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143685: Hedgehog Cervical Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143685

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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