510(k) · Cleared
Recalled · Class II · 2021Endoskeleton TCS Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Aug 6, 2019 as substantially equivalent to K142940 (Titan Spine, LLC, 2015) and 4 other predicates after a 54-day review. Its family tree reaches back 24 generations to 1984. 1 of the 397 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Aug 6, 2019
- Review
- 54 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 24 generations to K841189 (1984). 396 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 397 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 2 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 1 generation backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- This deviceK191565 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc. · 2019
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160955 Tritanium® PL CageStryker · 2016
- 4 generations backK162262 Tritanium® PL CageStryker · 2016
- 3 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 2 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 1 generation backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- This deviceK191565 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc. · 2019
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −4 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −2 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −1 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| 0 (this device) | K191565 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 16 | 0 |
| 2004 | 27 | 0 |
| 2005 | 20 | 0 |
| 2006 | 12 | 0 |
| 2007 | 17 | 0 |
| 2008 | 47 | 1 |
| 2009 | 36 | 0 |
| 2010 | 26 | 0 |
| 2011 | 35 | 0 |
| 2012 | 22 | 0 |
| 2013 | 18 | 0 |
| 2014 | 24 | 0 |
| 2015 | 17 | 0 |
| 2016 | 18 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 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.
1 device in this family has a Class I recall. 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | K142940 | Endoskeleton TCS SystemSummary page 4…87- Orthopedic Product Code: OVE Predicate Devices: Primary Predicate: Titan Spine Endoskeleton® TCS Interbody Fusion Device - K142940, K153122, K173535, & K183557 Secondary Predicate: Life S… | 2015 |
| * | K153122 | Endoskeleton (r) TCS SystemSummary page 4…opedic Product Code: OVE Predicate Devices: Primary Predicate: Titan Spine Endoskeleton® TCS Interbody Fusion Device - K142940, K153122, K173535, & K183557 Secondary Predicate: Life Spine Pro-… | 2015 |
| * | K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Summary page 4…VE Predicate Devices: Primary Predicate: Titan Spine Endoskeleton® TCS Interbody Fusion Device - K142940, K153122, K173535, & K183557 Secondary Predicate: Life Spine Pro-Link Ti Stand Alone Cervical Spac… | 2018 |
| * | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Summary page 4…te Devices: Primary Predicate: Titan Spine Endoskeleton® TCS Interbody Fusion Device - K142940, K153122, K173535, & K183557 Secondary Predicate: Life Spine Pro-Link Ti Stand Alone Cervical Spacer System -… | 2019 |
| * | K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer SystemSummary page 4…K173535, & K183557 Secondary Predicate: Life Spine Pro-Link Ti Stand Alone Cervical Spacer System - K180642 Device Description: The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a var… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2021 | Class II | Z-0086-2022 | Packaging change control | Engraving on implants may not match what is listed on the pouch labels. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 49 of the 396 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K142940.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The device is…
Read the full statement (118 words)
The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/or corticocancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191565: Endoskeleton TCS 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/K191565
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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