510(k) · Cleared
ClearedTalos-C Cervical Intervertebral Body Fusion Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech Advisors, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 28, 2013 after a 191-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 240 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 191 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
240 later devices descend from it, 2 citing it directly.
- This deviceK122850 Talos-C Cervical Intervertebral Body Fusion DevicesMeditech Advisors, LLC · 2013
- Descendant · cites it directly · 239 of its ownK142345 Talos-C (HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC · 2015
- Descendant · cites it directly · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- Descendant · 2 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 3 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 4 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
Showing 5 of 240 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 240 · See all- K142345Talos-C (HA) Cervical Intervertebral Body Fusion DevicesMeditech Spine, LLC · 2015 · cites it directly239descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122850 | Talos-C Cervical Intervertebral Body Fusion Devices | Meditech Advisors, LLC | 2013 | — |
| +1 | K142345 | Talos-C (HA) Cervical Intervertebral Body Fusion Devices | Meditech Spine, LLC | 2015 | — |
| +1 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| +2 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +4 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 19 | 0 |
| 2020 | 17 | 0 |
| 2021 | 17 | 0 |
| 2022 | 23 | 0 |
| 2023 | 31 | 0 |
| 2024 | 35 | 0 |
| 2025 | 39 | 0 |
| 2026 | 33 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (240)
See all 2402 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K142345 (Meditech Spine, LLC, 2015) has gone furthest, with 239 descendants of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Tabos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device 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 (126 words)
The Tabos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device 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. Tabos®-C Cervical IBE Devices are intended to be used with autologous bone graft to facilitate fusion.
Non-operative treatment prior to treatment with Tabos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Tabos®-C Cervical IBE Devices are to be implanted via an open anterior approach. Tabos®-C Cervical IBF Devices are also to be used with supplemental fixation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122850 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122850: Talos-C Cervical Intervertebral Body Fusion Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122850
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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