510(k) · Cleared
ClearedEndoskeleton TC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 29, 2010 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 3 other predicates after a 120-day review. Its family tree reaches back 12 generations to 2001. 455 later devices descend from it.
- Decided
- Jul 29, 2010
- Review
- 120 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K003155 (2001). 55 ancestors in all, the oldest K841189 (1984). 455 later devices descend from it, 12 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- This deviceK100889 Endoskeleton TCTitan Spine, LLC · 2010
- Descendant · cites it directly · 289 of its ownK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- Descendant · 2 generations on · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 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 · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 6 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 5 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 4 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 3 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 2 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 1 generation backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- This deviceK100889 Endoskeleton TCTitan Spine, LLC · 2010
Showing 5 of 455 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 455 · See all- K121649Construx Mini Peek TI Spacer SystemOrthofix · 2012 · cites it directly289descendants
- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · 2 generations on280descendants
- 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
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · 3 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −6 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −4 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −1 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| 0 (this device) | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| +1 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| +2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +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 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 10 | 0 |
| 2016 | 16 | 0 |
| 2017 | 25 | 0 |
| 2018 | 24 | 0 |
| 2019 | 37 | 0 |
| 2020 | 42 | 0 |
| 2021 | 37 | 0 |
| 2022 | 42 | 0 |
| 2023 | 55 | 0 |
| 2024 | 52 | 0 |
| 2025 | 57 | 0 |
| 2026 | 50 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 2…to be substantially equivalent to legally marketed predicate devices. The predicate devices include the OAK/Co Interbody Device by Zimmer Spine/Spine-Tech (P980048), the Phantom' TM Plus Cage System by US Spine (K082801), the Zeus by Interbody Innovations (KO81614), and the Aesculap® C… | 2001 |
| * | K082801 | Phantom Plus Cage SystemSummary page 2…predicate devices. The predicate devices include the OAK/Co Interbody Device by Zimmer Spine/Spine-Tech (P980048), the Phantom' TM Plus Cage System by US Spine (K082801), the Zeus by Interbody Innovations (KO81614), and the Aesculap® CeSpace PEEK Spinal Implant System (K08331 1). I… | 2008 |
| * | K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages | 2008 |
| * | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion SystemSummary page 2…the Phantom' TM Plus Cage System by US Spine (K082801), the Zeus by Interbody Innovations (KO81614), and the Aesculap® CeSpace PEEK Spinal Implant System (K08331 1). Intended Use I Indications far Use The Endoskeleton® TO is indicated for use for anterior cervical interbody fusion i… | 2009 |
What descends from it? (455)
See all 45512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121649 | Construx Mini Peek TI Spacer System | 2012 | 289 |
| K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL | 2014 | 265 |
| K142940 | Endoskeleton TCS System | 2015 | 111 |
| K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS… | 2014 | 106 |
| K160154 | ALTA Anterior Cervical Interbody Spacer | 2016 | 63 |
| K121741 | 4-Web Cervical STS (Spinal Truss System) | 2012 | 35 |
| K112862 | Mecta-C | 2011 | 14 |
| K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | 2016 | 6 |
| K240838 | Spectrum Spine Cervical Cage System | 2024 | 4 |
| K181261 | Curiteva Cervical Interbody Fusion System | 2018 | 4 |
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 9 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 3 of the 55 ancestors have a recall of any class.
- Of its descendants, K121649 (Orthofix, 2012) has gone furthest, with 289 descendants of its own.
- 53 other devices also cite its predicate P980048.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100889: Endoskeleton TC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100889
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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