510(k) · Cleared
ClearedEndoskeleton (R) TL Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 2, 2014 as substantially equivalent to K102067 (Titan Spine, LLC, 2010) and 2 other predicates after a 173-day review. Its family tree reaches back 7 generations to 2001. 267 later devices descend from it.
- Decided
- Jul 2, 2014
- Review
- 173 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003275 (2001). 22 ancestors in all, the oldest K841189 (1984). 267 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 6 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 5 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- 4 generations backK032812 Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc. · 2003 · Recalled
- 3 generations backK080615 Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC · 2008
- 2 generations backK083714 Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC · 2009
- 1 generation backK102067 Endoskeleton toTitan Spine, LLC · 2010
- This deviceK140055 Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC · 2014
- Descendant · cites it directly · 265 of its ownK141953 Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014 · Recalled
- Descendant · 2 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- Descendant · 3 generations on · 189 of its ownK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- Descendant · 4 generations on · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 2 generations on · 143 of its ownK163269 Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS…Titan Spine, LLC · 2017
Showing 5 of 267 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 267 · See all- K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014 · cites it directly265descendants
- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 2 generations on236descendants
- K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA · 2016 · 3 generations on189descendants
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · 4 generations on161descendants
- K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC · 2017 · 2 generations on143descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −6 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −5 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| −4 | K032812 | Endoskeleton TA Vertebral Body Replacement | Orthovita, Inc. | 2003 | 1 |
| −3 | K080615 | Endoskeleton TA Interbody Fusion Device (Ibd) | Titan Spine, LLC | 2008 | — |
| −2 | K083714 | Endoskeleton TT Interbody Fusion Device (Ibd) | Titan Spine, LLC | 2009 | — |
| −1 | K102067 | Endoskeleton to | Titan Spine, LLC | 2010 | — |
| 0 (this device) | K140055 | Endoskeleton (R) TL Interbody Fusion Device | Titan Spine, LLC | 2014 | — |
| +1 | K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL | Titan Spine, LLC | 2014 | 2 |
| +2 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| +3 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| +4 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +2 | K163269 | Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS… | Titan Spine, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 10 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 24 | 0 |
| 2022 | 31 | 0 |
| 2023 | 31 | 0 |
| 2024 | 40 | 0 |
| 2025 | 44 | 0 |
| 2026 | 38 | 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? (3)
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 |
|---|---|---|---|
| * | K102067 | Endoskeleton toSummary page 2…pect to indications for use, design, dimension, and materials to the following inierbody devices, previously cleared by the FDA: *Titan Spine: Endloskeleton® TO - K102067 *Titan Spine: Endoskeleton(r) TA VBR - K(032812 * Nuvasive XLIF - K(071795 The Indications for Use, Materials, and G… | 2010 |
| * | K032812 | Endoskeleton TA Vertebral Body ReplacementSummary page 2…erials to the following inierbody devices, previously cleared by the FDA: *Titan Spine: Endloskeleton® TO - K102067 *Titan Spine: Endoskeleton(r) TA VBR - K(032812 * Nuvasive XLIF - K(071795 The Indications for Use, Materials, and Geometry for predicate devices are all inclusive of the… | 2003 |
| * | K071795 | Nuvasive Coroent SystemSummary page 2…devices, previously cleared by the FDA: *Titan Spine: Endloskeleton® TO - K102067 *Titan Spine: Endoskeleton(r) TA VBR - K(032812 * Nuvasive XLIF - K(071795 The Indications for Use, Materials, and Geometry for predicate devices are all inclusive of the subject device. The difference b… | 2007 |
What descends from it? (267)
See all 2673 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 13 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K141953 (Titan Spine, LLC, 2014) has gone furthest, with 265 descendants of its own.
- 5 other devices also cite its predicate K102067.
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. 2014, 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 Endoskeleton®g TL IBO is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. This device is intended for use with…
Read the full statement (122 words)
The Endoskeleton®g TL IBO is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. This device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140055: Endoskeleton (R) TL Interbody 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/K140055
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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