510(k) · Cleared
ClearedEndoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion Device
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 Apr 13, 2017 as substantially equivalent to K123045 (Nuvasive, Inc., 2013) and 4 other predicates after a 143-day review. Its family tree reaches back 14 generations to 1984. 143 later devices descend from it.
- Decided
- Apr 13, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K841189 (1984). 95 ancestors in all. 143 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- This deviceK163269 Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS…Titan Spine, LLC · 2017
- Descendant · cites it directly · 105 of its ownK173535 Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, LLC · 2018 · Recalled
- Descendant · 2 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · cites it directly · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- Descendant · 2 generations on · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- This deviceK163269 Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS…Titan Spine, LLC · 2017
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC · 2018 · cites it directly105descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 2 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 2 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · cites it directly81descendants
- K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −4 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −3 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −1 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| 0 (this device) | K163269 | Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS… | Titan Spine, LLC | 2017 | — |
| +1 | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic… | Titan Spine, LLC | 2018 | 2 |
| +2 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +2 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +1 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| +2 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 13 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 11 | 0 |
| 2022 | 17 | 0 |
| 2023 | 16 | 0 |
| 2024 | 29 | 0 |
| 2025 | 29 | 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 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? (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 |
|---|---|---|---|
| * | K123045 | Brigade Standalone SystemSummary page 4…87- Orthopedic Product Code: OVD Predicate Devices: Primary Predicate NuVasive Inc. Brigade Hyperlordotic System (K123045 S.E. June 16, 2013) Additional Predicates Titan Spine Endoskeleton® TAS (K… | 2013 |
| * | K111626 | Endoskeleton (R) TasSummary page 4…nc. Brigade Hyperlordotic System (K123045 S.E. June 16, 2013) Additional Predicates Titan Spine Endoskeleton® TAS (K111626 S.E. September 9, 2011) Titan Spine Endoskeleton® TA (K080615 S.E. June 17, 2008)… | 2011 |
| * | K080615 | Endoskeleton TA Interbody Fusion Device (Ibd)Summary page 4…Additional Predicates Titan Spine Endoskeleton® TAS (K111626 S.E. September 9, 2011) Titan Spine Endoskeleton® TA (K080615 S.E. June 17, 2008) Titan Spine nanoLOCK® Surface Technology (K141953 S.E. October 27, 2014)… | 2008 |
| * | K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLSummary page 4…tember 9, 2011) Titan Spine Endoskeleton® TA (K080615 S.E. June 17, 2008) Titan Spine nanoLOCK® Surface Technology (K141953 S.E. October 27, 2014) Centinel Spine/Surgicraft STALIF TT (K073109 S.E. June 4, 2008) Device Descri… | 2014 |
| * | K073109 | Stalif TT Intervertebral Body Fusion SystemSummary page 4…2008) Titan Spine nanoLOCK® Surface Technology (K141953 S.E. October 27, 2014) Centinel Spine/Surgicraft STALIF TT (K073109 S.E. June 4, 2008) Device Description: The Endoskeleton® TAS Interbody Fusion Device and Endoskeleton® TAS Hyperlordotic Interb… | 2008 |
What descends from it? (143)
See all 1434 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody… | 2018 | 105 |
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion… | 2020 | 81 |
| K182139 | AXTi Titanium Stand-Alone ALIF System | 2019 | 72 |
| 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 33 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 95 ancestors have a recall of any class.
- Of its descendants, K173535 (Titan Spine, LLC, 2018) has gone furthest, with 105 descendants of its own.
- 16 other devices also cite its predicate K123045.
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. 2017, 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of…
Read the full statement (234 words)
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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The device is indicated to be used with autograft bone.
Hyperlordotic Devices ≥16°
The Endoskeleton® TAS Hyperlordotic Interbody Fusion Device (≥16°) 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone. The Endoskeleton® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163269 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163269: Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163269
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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