510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Endoskeleton TCS System

K142940510(k) TraditionalCleared Jan 28, 2015111-day reviewClass II21 CFR 888.3080Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Titan Spine, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Jan 28, 2015 as substantially equivalent to K100889 (Titan Spine, LLC, 2010) and 7 other predicates after a 111-day review. Its family tree reaches back 15 generations to 1984. 111 later devices descend from it. It has been recalled 2 times.

Decided
Jan 28, 2015
Review
111 days
Class
Class II
Product code
OVE
Recalls
2
Predicates
8

Its longest line of descent runs back 15 generations to K841189 (1984). 137 ancestors in all, the oldest K792352 (1979). 111 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 4 other ancestors2011: 3 other ancestors2010: 2 other ancestors2009: 7 other ancestors2008: 19 other ancestors2007: 8 other ancestors2006: 6 other ancestors2005: 13 other ancestors2002: 8 other ancestors2001: 10 other ancestors2004: 22 other ancestors1999: 2 other ancestors1996: 2 other ancestors2003: 12 other ancestors2000: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2015: 2 descendants cleared2019: 4 descendants cleared2016: 1 descendant cleared2018: 2 descendants cleared2023: 11 descendants cleared2020: 4 descendants cleared2021: 8 descendants cleared2024: 22 descendants cleared2025: 22 descendants cleared2022: 11 descendants cleared2026: 24 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×3: 3 generations cleared close together, K072120 (2007), K080083 (2008), K073109 (2008) K083475 · Lucent Magnum · Spinal Elements, Inc. · 2009K092211 · Chesapeake Spinal System · K2m, Inc. · 2010K111439 · Chesapeake (Cervical Components) · K2m, Inc. · 2011 · recalledK133494 · Chesapeake Spinal System · K2m, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 15 other ancestors3 generations back: 26 other ancestors4 generations back: 40 other ancestors5 generations back: 25 other ancestors6 generations back: 7 other ancestors7 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 8 descendants4 generations forward: 13 descendants5 generations forward: 26 descendants6 generations forward: 31 descendants7 generations forward: 18 descendants8 generations forward: 8 descendants9 generations forward: 1 descendant K133494 · Chesapeake Spinal System · K2m, Inc. · 2014K111439 · Chesapeake (Cervical Components) · K2m, Inc. · 2011 · recalledK092211 · Chesapeake Spinal System · K2m, Inc. · 2010K083475 · Lucent Magnum · Spinal Elements, Inc. · 2009K073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−15−10−50+5
  1. Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations between
  3. 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
  4. 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
  5. 1 generation backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
  6. This deviceK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015
  7. Descendant · cites it directly · 110 of its ownK151596 Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · Recalled
  8. Descendant · cites it directly · 106 of its ownK153122 Endoskeleton (r) TCS SystemTitan Spine, LLC · 2015 · Recalled
  9. Descendant · 2 generations on · 105 of its ownK173535 Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, LLC · 2018 · Recalled
  10. Descendant · 3 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
  11. Descendant · 2 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 15 generations
  1. Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 4 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
  13. 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
  14. 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
  15. 1 generation backK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
  16. This deviceK142940 Endoskeleton TCS SystemTitan Spine, LLC · 2015

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12018: 22019: 42020: 42021: 82022: 112023: 112024: 222025: 222026: 24
2015high 24 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 111 · See all
  • K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 2015 · cites it directly110descendants
  • K153122Endoskeleton (r) TCS SystemTitan Spine, LLC · 2015 · cites it directly106descendants
  • K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC · 2018 · 2 generations on105descendants
  • K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 3 generations on104descendants
  • K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 2 generations on102descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−14K990148Stackable Cage SystemDepuy Motech Acromed1999—
−13K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−12K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−11K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−10K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−9K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−8K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−7K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−6K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−5K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−4K083475Lucent MagnumSpinal Elements, Inc.2009—
−3K092211Chesapeake Spinal SystemK2m, Inc.2010—
−2K111439Chesapeake (Cervical Components)K2m, Inc.20111
−1K133494Chesapeake Spinal SystemK2m, Inc.2014—
0 (this device)K142940Endoskeleton TCS SystemTitan Spine, LLC2015—
+1K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151
+1K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151
+2K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic…Titan Spine, LLC20182
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion…Titan Spine, Inc.20193
+2K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199620
199810
199920
200010
2001100
200280
2003120
2004220
2005130
200660
200780
2008190
200970
201020
201130
201240

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201820
201940
202040
202180
2022110
2023110
2024220
2025220
2026240
FIG. 1 — Lineage of K142940, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K100889Endoskeleton TC
Summary page 5
…ion device) Panel: 87- Orthopedic Product Code: OVE ODP Predicate Devices: Primary Predicate Titan Spine Endoskeleton® TC (K100889 S.E. July 29, 2010) Additional Predicates K2M Chesapeake Spinal System (K133494 S.E. J…
Titan Spine, LLC2010—
*K133494Chesapeake Spinal System
Summary page 5
…Titan Spine Endoskeleton® TC (K100889 S.E. July 29, 2010) Additional Predicates K2M Chesapeake Spinal System (K133494 S.E. June 10, 2014) Surgicraft STALIF™ C (K072415 S.E. January 25, 2006) Centinel Spine…
K2m, Inc.2014—
*K072415Stalif (TM) C
Summary page 5
…10) Additional Predicates K2M Chesapeake Spinal System (K133494 S.E. June 10, 2014) Surgicraft STALIF™ C (K072415 S.E. January 25, 2006) Centinel Spine STALIF® (K120819 S.E. August 31, 2012) LDR Spine…
Surgicraft, Ltd.2008—
*K120819Stalif C
Summary page 5
…sapeake Spinal System (K133494 S.E. June 10, 2014) Surgicraft STALIF™ C (K072415 S.E. January 25, 2006) Centinel Spine STALIF® (K120819 S.E. August 31, 2012) LDR Spine Cervical Interbody Fusion System (K091088 S.E. July 14,…
Centinel Spine, Inc.2012—
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 5
…072415 S.E. January 25, 2006) Centinel Spine STALIF® (K120819 S.E. August 31, 2012) LDR Spine Cervical Interbody Fusion System (K091088 S.E. July 14, 2009) LDR Spine Cervical Interbody Fusion System – ROI-C Lordotic…
Ldr Spine USA2009—
*K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants
Summary page 5
…88 S.E. July 14, 2009) LDR Spine Cervical Interbody Fusion System – ROI-C Lordotic Implants (K113559 S.E. December 29, 2011) Medtronic PEEK PREVAIL® Cervical Interbody Device (K113252 S.E.…
Ldr Spine USA, Inc.2011—
*K113252Peek Prevail Cervical Interbody Device
Summary page 5
…ion System – ROI-C Lordotic Implants (K113559 S.E. December 29, 2011) Medtronic PEEK PREVAIL® Cervical Interbody Device (K113252 S.E. K142940…
Medtronic Sofamor Danek2012—
*K073285Peek Prevail Cervical Interbody Device
Summary page 6
…Page 2 of 3 January 17, 2012) Medtronic PEEK PREVAIL™ Cervical Interbody Device (K073285 S.E. May 15, 2008) Device Description: The Endoskeleton® TCS Interbody Fusion Device (IBD) implants…
Medtronic Sofamor Danek USA, Inc.2008—

Also cleared against K100889: 11 other devices →

What descends from it? (111)

See all 111

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC2015110
K153122Endoskeleton (r) TCS SystemTitan Spine, LLC2015106
K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 20, 2015Class IIZ-2327-2015Nonconforming Material/ComponentTitan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Feb 20, 2015Class IIZ-1324-2015Nonconforming Material/ComponentThe TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6…

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 1.0 years on median.
  • 14 of the 137 ancestors have a recall of any class.
  • Of its descendants, K151596 (Titan Spine, LLC, 2015) has gone furthest, with 110 descendants of its own.
  • 11 other devices also cite its predicate K100889.

How does its category compare?

All OVE devices

OVE 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

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

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 in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K100889

11 other devices cite the same predicate.

  • K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc. · 2024
  • K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 2018
  • K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017
  • K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd. · 2017
  • K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
  • K160154ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016

More from Titan Spine, LLC

14 FDA decisions under this applicant name. See the company

  • K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and…Titan Spine, LLC · 20182 recalls
  • K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC · 2017
  • K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion DeviceTitan Spine, LLC · 2017
  • K153122Endoskeleton (r) TCS SystemTitan Spine, LLC · 20151 recall
  • K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC · 20151 recall

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K142940 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142940: Endoskeleton 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/K142940

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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