510(k) Report

510(k) · Cleared

Cleared

Talos-C (HA) Cervical Intervertebral Body Fusion Devices

K142345510(k) TraditionalCleared Feb 22, 2015184-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

Meditech Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Feb 22, 2015 as substantially equivalent to K122850 (Meditech Advisors, LLC, 2013) after a 184-day review. Its family tree reaches back 1 generation to 2013. 239 later devices descend from it.

Decided
Feb 22, 2015
Review
184 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K122850 (2013). 239 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2016: 3 descendants cleared2015: 1 descendant cleared2022: 23 descendants cleared2021: 17 descendants cleared2020: 17 descendants cleared2017: 12 descendants cleared2025: 39 descendants cleared2019: 19 descendants cleared2018: 9 descendants cleared2023: 31 descendants cleared2024: 35 descendants cleared2026: 33 descendants clearedK122850 · Talos-C Cervical Intervertebral Body Fusion Devices · Meditech Advisors, LLC · 20132010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 19 descendants4 generations forward: 42 descendants5 generations forward: 48 descendants6 generations forward: 26 descendants7 generations forward: 13 descendants8 generations forward: 16 descendants9 generations forward: 23 descendants10 generations forward: 26 descendants11 generations forward: 12 descendants12 generations forward: 3 descendants13 generations forward: 1 descendant K122850 · Talos-C Cervical Intervertebral Body Fusion Devices · Meditech Advisors, LLC · 20130+5+10
  1. Root · 1 generation backK122850 Talos-C Cervical Intervertebral Body Fusion DevicesMeditech Advisors, LLC · 2013
  2. This deviceK142345 Talos-C (HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC · 2015
  3. Descendant · cites it directly · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
  4. Descendant · 2 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  5. Descendant · 3 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
  6. Descendant · 4 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
  7. Descendant · 5 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled

Showing 5 of 239 descendants. See all descendants

Descendants cleared per year

2015: 12016: 32017: 122018: 92019: 192020: 172021: 172022: 232023: 312024: 352025: 392026: 33
2015high 39 (2025) · low 1 (2015)2026

Most influential descendants

Showing 5 of 239 · See all
  • K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · cites it directly202descendants
  • K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 2 generations on166descendants
  • K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 3 generations on129descendants
  • K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 4 generations on106descendants
  • K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 5 generations on104descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K122850Talos-C Cervical Intervertebral Body Fusion DevicesMeditech Advisors, LLC2013—
0 (this device)K142345Talos-C (HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC2015—
+1K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral…Meditech Spine, LLC2015—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion…Titan Spine, Inc.20193

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201630
2017120
201890
2019190
2020170
2021170
2022230
2023310
2024350
2025390
2026330
FIG. 1 — Lineage of K142345, 2013–2026Source: 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 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
*K122850Talos-C Cervical Intervertebral Body Fusion Devices
Summary page 4
…e: Intervertebral body fusion device (21 CFR 888.3080 Class II, Product Code ODP) C. Predicate Device: K 122850: Meditech Advisors, LLC Talos®‐C Cervical Intervertebral Body Fusion Devices D. Device Desc…
Meditech Advisors, LLC2013—

Also cleared against K122850: 1 other device →

What descends from it? (239)

See all 239

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

NumberDeviceApplicantDecidedDescendants
K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202
K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650
K203444BEE HA CageNGMedical GmbH20211
K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220

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?

  • Its one ancestor has no recall.
  • Of its descendants, K150788 (Meditech Spine, LLC, 2015) has gone furthest, with 202 descendants of its own.
  • 1 other device also cites its predicate K122850.

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?

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord…

Read the full statement (129 words)

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.

Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.

Indications for use as stated in the FDA summary.

Also cleared against K122850

1 other device cites the same predicate.

  • K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C…Meditech Spine, LLC · 2015

More from Meditech Spine, LLC

10 FDA decisions under this applicant name. See the company

  • K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2021
  • K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion SystemMeditech Spine, LLC · 2020
  • K201136Cure™ Lumbar Plate SystemMeditech Spine, LLC · 2020
  • K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC · 2018
  • K180090Cure™ Lumbar Plate SystemMeditech Spine, LLC · 2018

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/K142345 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142345: Talos-C (HA) Cervical Intervertebral Body Fusion Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142345

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