510(k) · Cleared
ClearedTalos® Lumbar (HA) PEEK IBF Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 2, 2017 as substantially equivalent to K150788 (Meditech Spine, LLC, 2015) and 1 other predicate after a 114-day review. Its family tree reaches back 18 generations to 1984. 10 later devices descend from it.
- Decided
- Jun 2, 2017
- Review
- 114 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K841189 (1984). 143 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- This deviceK170395 Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC · 2017
- Descendant · cites it directly · 6 of its ownK181589 Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK233744 Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK250845 Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK180891 EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2018
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 4 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- This deviceK170395 Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC · 2018 · cites it directly6descendants
- K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc. · 2024 · 2 generations on2descendants
- K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc. · 2025 · 3 generations on1descendant
- K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021 · 2 generations on1descendant
- K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −5 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −4 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −1 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| 0 (this device) | K170395 | Talos® Lumbar (HA) PEEK IBF Devices | Meditech Spine, LLC | 2017 | — |
| +1 | K181589 | Curiteva Lumbar Interbody Fusion System | Curiteva, LLC | 2018 | — |
| +2 | K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | 2024 | — |
| +3 | K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025 | — |
| +2 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +1 | K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2018 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Summary page 4…Intervertebral body fusion device (21 CFR888.3080Class II, ProductCodeMAX) C. PredicateDevices: K150788:MeditechSpine,LLCTalos®IntervertebralBodyFusion Devices(Primary)… | 2015 |
| * | K090707 | Talos Intervertebral Body Fusion DeviceSummary page 4…K150788:MeditechSpine,LLCTalos®IntervertebralBodyFusion Devices(Primary) K090707:MeditechAdvisors,LLCTalos®IntervertebralBody FusionDevices(Ad ditional) D.D… | 2009 |
What descends from it? (10)
3 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?
- The line of descent spans 33 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 13 of the 143 ancestors have a recall of any class.
- Of its descendants, K181589 (Curiteva, LLC, 2018) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K150788.
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. 2017, 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 Talos® Lumbar (HA) PEEK 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® Lumbar (HA) PEEK IBF devices are intended to be used…
Read the full statement (175 words)
The Talos® Lumbar (HA) PEEK 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® Lumbar (HA) PEEK IBF devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The Talos® Lumbar (HA) PEEK IBF Device is to be used in patients who have had six months of non-operative treatment.
Talos® Lumbar (HA) PEEK IBF devices are to be implanted via a direct posterior, transforaminal, lateral, anterior or anteriolateral approach in the lumbosacral spine. The Talos®-P (HA), Talos®-P WB (HA), Talos®-TL (HA), Talos®-T (HA), Talos®-L (HA), and Talos®-A (HA) are intended to be used with supplemental fixation.
Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170395: Talos® Lumbar (HA) PEEK IBF Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170395
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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