510(k) · Cleared
ClearedTalos Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech Advisors, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 15, 2009 after a 120-day review. The FDA summary names no predicate by number. 281 later devices descend from it.
- Decided
- Jul 15, 2009
- Review
- 120 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
281 later devices descend from it, 5 citing it directly.
- This deviceK090707 Talos Intervertebral Body Fusion DeviceMeditech Advisors, LLC · 2009
- 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
- Descendant · 5 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 281 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090707 | Talos Intervertebral Body Fusion Device | Meditech Advisors, LLC | 2009 | — |
| +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 | — |
| +5 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 15 | 0 |
| 2018 | 14 | 0 |
| 2019 | 21 | 0 |
| 2020 | 23 | 0 |
| 2021 | 18 | 0 |
| 2022 | 28 | 0 |
| 2023 | 38 | 0 |
| 2024 | 39 | 0 |
| 2025 | 41 | 0 |
| 2026 | 36 | 0 |
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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (281)
See all 2815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion… | 2015 | 202 |
| K102957 | Cutting Edge Spine Interbody Fusion Device | 2011 | 93 |
| K170297 | Tranquil Interbody System | 2017 | 15 |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | 2017 | 10 |
| K143572 | Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance… | 2015 | 0 |
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, K150788 (Meditech Spine, LLC, 2015) has gone furthest, with 202 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The TalosTM IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. TalosTM IBF devices are intended to be used with autologous bone graft to…
Read the full statement (148 words)
The TalosTM IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. TalosTM IBF devices are intended to be used with autologous bone graft to facilitate fusion. The TalosTM IBF device is to be used in patients who have had six months of non-operative treatment.
Talos TM IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The TalosTM-P device is implanted in pairs, and the TalosTM-A, TalosTM-L and TalosTM-T devices may be implanted singly or in pairs in the lumbosacral spine. The TalosTM-A, TalosTM-L, TalosTM-P, and TalosTM-T are intended to be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090707: Talos Intervertebral Body 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/K090707
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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