510(k) · Cleared
Recalled · Class II · 2021Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL
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 Oct 27, 2014 as substantially equivalent to K111626 (Titan Spine, LLC, 2011) and 6 other predicates after a 101-day review. Its family tree reaches back 13 generations to 2001. 265 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 13 generations to K003155 (2001). 78 ancestors in all, the oldest K841189 (1984). 265 later devices descend from it, 8 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK141953 Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014
- Descendant · cites it directly · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- Descendant · 2 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 · 3 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
- Descendant · 4 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- This deviceK141953 Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014
Showing 5 of 265 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 265 · See all- K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · cites it directly236descendants
- K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA · 2016 · 2 generations on189descendants
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · 3 generations on161descendants
- K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC · 2017 · cites it directly143descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 4 generations on116descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −7 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −2 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| 0 (this device) | K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL | Titan Spine, LLC | 2014 | — |
| +1 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| +2 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| +3 | 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 | — |
| +4 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 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 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K111626 | Endoskeleton (R) TasSummary page 8…valence: The proposed modifications to the Endoskeleton® devices are identical to predicate devices previously cleared by Titan Spine: Predicate: Endoskeleton TAS – K111626 Other predicates: Endoskeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC –… | 2011 |
| * | K080615 | Endoskeleton TA Interbody Fusion Device (Ibd)Summary page 8…eleton® devices are identical to predicate devices previously cleared by Titan Spine: Predicate: Endoskeleton TAS – K111626 Other predicates: Endoskeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC – K100889, Endoskeleton TL – K140055 and End… | 2008 |
| * | K083714 | Endoskeleton TT Interbody Fusion Device (Ibd)Summary page 8…al to predicate devices previously cleared by Titan Spine: Predicate: Endoskeleton TAS – K111626 Other predicates: Endoskeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC – K100889, Endoskeleton TL – K140055 and Endoskeleton TA VBR – K032812… | 2009 |
| * | K102067 | Endoskeleton toSummary page 8…cleared by Titan Spine: Predicate: Endoskeleton TAS – K111626 Other predicates: Endoskeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC – K100889, Endoskeleton TL – K140055 and Endoskeleton TA VBR – K032812… | 2010 |
| * | K100889 | Endoskeleton TCSummary page 8… Predicate: Endoskeleton TAS – K111626 Other predicates: Endoskeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC – K100889, Endoskeleton TL – K140055 and Endoskeleton TA VBR – K032812… | 2010 |
| * | K140055 | Endoskeleton (R) TL Interbody Fusion DeviceSummary page 8…111626 Other predicates: Endoskeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC – K100889, Endoskeleton TL – K140055 and Endoskeleton TA VBR – K032812… | 2014 |
| * | K032812 | Endoskeleton TA Vertebral Body ReplacementSummary page 8…skeleton TA - K080615, Endoskeleton TT – K083714, Endoskeleton TO – K102067, Endoskeleton TC – K100889, Endoskeleton TL – K140055 and Endoskeleton TA VBR – K032812 K141953… | 2003 |
What descends from it? (265)
See all 2658 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152475 | FORZA PTC Spacer System | 2016 | 236 |
| K163269 | Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic… | 2017 | 143 |
| K153122 | Endoskeleton (r) TCS System | 2015 | 106 |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | 2017 | 105 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device… | 2019 | 104 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic… | 2019 | 102 |
| K181589 | Curiteva Lumbar Interbody Fusion System | 2018 | 6 |
| K192054 | Endoskeleton TAS Plate | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2021 | Class II | Z-0085-2022 | Packaging change control | Engraving on implants may not match what is listed on the pouch labels. |
| Mar 17, 2021 | Class II | Z-1440-2021 | Packaging process control | The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small 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 6 companies; a new generation was cleared every 10 months on median.
- 8 of the 78 ancestors have a recall of any class.
- Of its descendants, K152475 (Orthofix, Inc., 2016) has gone furthest, with 236 descendants of its own.
- 4 other devices also cite its predicate K111626.
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® TA 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 device. The device may be used with supplemental fixation.…
Read the full statement (652 words)
The ENDOSKELETON® TA 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 device. The device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
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 used with autograft bone.
The Endoskeleton® TO IBD 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 must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton® TT IBD 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 must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone.
The Endoskeleton® TL IBD 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-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. 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.
The ENDOSKELETON® TA VBR is for use in the thoracolumbar spine (T1 – L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The ENDOSKELETON® TA VBR is intended for use with supplemental internal spinal fixation systems. The ENDOSKELETON® TA VBR may be used with bone graft material or bone graft substitute.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141953
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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