510(k) · Cleared
Recalled · Class II · 2021Endoskeleton (r) TCS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Titan Spine, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 14, 2015 as substantially equivalent to K142940 (Titan Spine, LLC, 2015) and 2 other predicates after a 46-day review. Its family tree reaches back 17 generations to 1984. 106 later devices descend from it. It has been recalled once.
- Decided
- Dec 14, 2015
- Review
- 46 days
- Class
- Class II
- Product code
- OVE
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 17 generations to K841189 (1984). 148 ancestors in all, the oldest K792352 (1979). 106 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 2 generations backK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
- 1 generation backK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
- This deviceK153122 Endoskeleton (r) TCS SystemTitan Spine, LLC · 2015
- 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 · cites it directly · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- Descendant · 3 generations on · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 5 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 4 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 3 generations backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- 2 generations backK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015 · Recalled
- 1 generation backK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
- This deviceK153122 Endoskeleton (r) TCS SystemTitan Spine, LLC · 2015
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · 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 · cites it directly102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 2 generations on81descendants
- K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · 3 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −5 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −4 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −3 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| −2 | K142940 | Endoskeleton TCS System | Titan Spine, LLC | 2015 | 2 |
| −1 | K151596 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, LLC | 2015 | 1 |
| 0 (this device) | K153122 | Endoskeleton (r) TCS System | Titan Spine, LLC | 2015 | — |
| +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 |
| +1 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +2 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| +3 | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 22 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 20 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 8 | 0 |
| 2022 | 11 | 0 |
| 2023 | 10 | 0 |
| 2024 | 22 | 0 |
| 2025 | 22 | 0 |
| 2026 | 24 | 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 OVE? 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? (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 |
|---|---|---|---|
| * | K142940 | Endoskeleton TCS SystemSummary page 4…888.3080 (Intervertebral body fusion device) Panel: 87- Orthopedic Product Code: OVE, ODP Primary Predicate: Titan Spine Endoskeleton® TCS (K142940 S.E. 01/28/2015) Additional Predicates: Titan Spine Endoskeleton® TCS (K151596 S.E. 10/09/2015) Endoskelet… | 2015 |
| * | K151596 | Endoskeleton TCS Interbody Fusion DeviceSummary page 4…dic Product Code: OVE, ODP Primary Predicate: Titan Spine Endoskeleton® TCS (K142940 S.E. 01/28/2015) Additional Predicates: Titan Spine Endoskeleton® TCS (K151596 S.E. 10/09/2015) Endoskeleton® System (K141953 S.E. 10/27/2014) Device Description: The Endoskeleton® TCS… | 2015 |
| * | K141953 | Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLSummary page 4…e Endoskeleton® TCS (K142940 S.E. 01/28/2015) Additional Predicates: Titan Spine Endoskeleton® TCS (K151596 S.E. 10/09/2015) Endoskeleton® System (K141953 S.E. 10/27/2014) Device Description: The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of… | 2014 |
What descends from it? (106)
See all 1063 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0086-2022 | Packaging change control | Engraving on implants may not match what is listed on the pouch labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 12 companies; a new generation was cleared every 9 months on median.
- 18 of the 148 ancestors have a recall of any class.
- Of its descendants, K173535 (Titan Spine, LLC, 2018) has gone furthest, with 105 descendants of its own.
- 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. 2015, 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 System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck 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. The device is a stand-alone system when used with Endoskeleton® TCS 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/K153122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153122: Endoskeleton (r) TCS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153122
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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