510(k) · Cleared
ClearedEndoskeleton (R) Tas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Spine, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Sep 9, 2011 as substantially equivalent to K080615 (Titan Spine, LLC, 2008) and 2 other predicates after a 91-day review. Its family tree reaches back 11 generations to 1984. 273 later devices descend from it.
- Decided
- Sep 9, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 41 ancestors in all. 273 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK111626 Endoskeleton (R) TasTitan Spine, LLC · 2011
- 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 · cites it directly · 143 of its ownK163269 Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS…Titan Spine, LLC · 2017
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 1 generation backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- This deviceK111626 Endoskeleton (R) TasTitan Spine, LLC · 2011
Showing 5 of 273 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 273 · 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 · cites it directly143descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| 0 (this device) | K111626 | Endoskeleton (R) Tas | Titan Spine, LLC | 2011 | — |
| +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 | — |
| +1 | 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 |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 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 | 11 | 0 |
| 2019 | 13 | 0 |
| 2020 | 21 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 33 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K080615 | Endoskeleton TA Interbody Fusion Device (Ibd)Summary page 1…Endoskeletona TAS was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are the Endloskeleton TA Interbody Fusion Device (K080615) and the Stalif TT (K073109) and the BAK Lumbar device (P3950002). Intended Use / Indications for Use The Endoskeleton' TAS Inte… | 2008 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 1…to be substantially equivalent to legally marketed predicate devices. The predicate devices are the Endloskeleton TA Interbody Fusion Device (K080615) and the Stalif TT (K073109) and the BAK Lumbar device (P3950002). Intended Use / Indications for Use The Endoskeleton' TAS Interbody Fusion Device is indic… | 2008 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…lly marketed predicate devices. The predicate devices are the Endloskeleton TA Interbody Fusion Device (K080615) and the Stalif TT (K073109) and the BAK Lumbar device (P3950002). Intended Use / Indications for Use The Endoskeleton' TAS Interbody Fusion Device is indicated for use in skeletally mature pat… | 1996 |
What descends from it? (273)
See all 2735 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL | 2014 | 265 |
| K163269 | Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic… | 2017 | 143 |
| K133827 | A-Link Z | 2014 | 26 |
| K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | 2018 | 18 |
| K192054 | Endoskeleton TAS Plate | 2019 | 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 27 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K141953 (Titan Spine, LLC, 2014) has gone furthest, with 265 descendants of its own.
- 6 other devices also cite its predicate K080615.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Endoskeleton TAS Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. 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. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
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/K111626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111626: Endoskeleton (R) Tas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111626
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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