510(k) · Cleared
ClearedTalos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Oct 14, 2015 as substantially equivalent to K142152 (Orthofix, Inc., 2015) and 4 other predicates after a 203-day review. Its family tree reaches back 17 generations to 1984. 202 later devices descend from it.
- Decided
- Oct 14, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 142 ancestors in all. 202 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- Descendant · cites it directly · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 2 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 3 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 4 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 5 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 4 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 202 · See all- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · cites it directly166descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 2 generations on129descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 3 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 4 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 5 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −4 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −2 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −1 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| 0 (this device) | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| +1 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +2 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +3 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +4 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +5 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 21 | 0 |
| 2009 | 15 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 11 | 0 |
| 2018 | 8 | 0 |
| 2019 | 18 | 0 |
| 2020 | 15 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 24 | 0 |
| 2024 | 31 | 0 |
| 2025 | 31 | 0 |
| 2026 | 29 | 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 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? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemSummary page 5…Intervertebral body fusion device (21 CFR 888.3080 Class II, Product Code MAX) C. Predicate Devices: K 142152: Orthofix CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, Cervical St… | 2015 |
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 5…CONSTRUX Mini PEEK Ti Spacer System, Cervical Stand Alone Device (Primary Predicate – Cervical) K 143163: Stryker AVS® Spacers and Cages (1st Additional – Lumbar)… | 2015 |
| * | K090707 | Talos Intervertebral Body Fusion DeviceSummary page 5…K 143163: Stryker AVS® Spacers and Cages (1st Additional – Lumbar) K 090707: Meditech Advisors, LLC Talos® Intervertebral Body Fusion Devices… | 2009 |
| * | K122850 | Talos-C Cervical Intervertebral Body Fusion DevicesSummary page 5…K 090707: Meditech Advisors, LLC Talos® Intervertebral Body Fusion Devices K 122850: Meditech Advisors, LLC Talos®‐C Cervical Intervertebral Body Fusion Devices… | 2013 |
| * | K142345 | Talos-C (HA) Cervical Intervertebral Body Fusion DevicesSummary page 5…K 122850: Meditech Advisors, LLC Talos®‐C Cervical Intervertebral Body Fusion Devices K 142345: Meditech Spine, LLC Talos®‐C (HA) Cervical Intervertebral Body Fusion Devices D. Device De… | 2015 |
What descends from it? (202)
See all 2024 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160924 | Amendia Interbody Fusion Devices | 2016 | 166 |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device… | 2016 | 27 |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | 2017 | 10 |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical… | 2020 | 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?
- The line of descent spans 31 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 13 of the 142 ancestors have a recall of any class.
- Of its descendants, K160924 (Amendia, Inc., 2016) has gone furthest, with 166 descendants of its own.
- 5 other devices also cite its predicate K142152.
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. 2015, 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?
Talos® Intervertebral Body Fusion Devices: The Talos® 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. Talos® IBF Devices are intended to be…
Read the full statement (410 words)
Talos® Intervertebral Body Fusion Devices:
The Talos® 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. Talos® IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The Talos® IBF Device is to be used in patients who have had six months of non-operative treatment.
Talos® IBF devices are to be implanted via a direct posterior, transforaminal, lateral, or anterior approach in the lumbosacral spine. The Talos®-A, Talos®-L, Talos®-P and Talos®-T are intended to be used with supplemental fixation.
Talos®-C Cervical Intervertebral Body Fusion Devices:
The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc (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 Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices:
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 autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, 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/K150788
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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