510(k) Report

510(k) · Cleared

Cleared

Endoskeleton TT Interbody Fusion Device (Ibd)

K083714510(k) TraditionalCleared Apr 15, 2009121-day reviewClass II21 CFR 888.3080

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

Titan Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 15, 2009 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) and 6 other predicates after a 121-day review. Its family tree reaches back 5 generations to 2001. 412 later devices descend from it.

Decided
Apr 15, 2009
Review
121 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K003275 (2001). 18 ancestors in all, the oldest K841189 (1984). 412 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2003: 2 other ancestors1999: 3 other ancestors1996: 2 other ancestors2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1984: 1 other ancestor2014: 4 descendants cleared2010: 1 descendant cleared2020: 39 descendants cleared2017: 9 descendants cleared2015: 2 descendants cleared2018: 16 descendants cleared2019: 19 descendants cleared2016: 8 descendants cleared2023: 55 descendants cleared2021: 38 descendants cleared2022: 49 descendants cleared2024: 63 descendants cleared2025: 60 descendants cleared2026: 49 descendants clearedK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 2003K032812 · Endoskeleton TA Vertebral Body Replacement · Orthovita, Inc. · 2003 · recalledK080615 · Endoskeleton TA Interbody Fusion Device (Ibd) · Titan Spine, LLC · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 24 descendants3 generations forward: 44 descendants4 generations forward: 59 descendants5 generations forward: 102 descendants6 generations forward: 100 descendants7 generations forward: 48 descendants8 generations forward: 19 descendants9 generations forward: 7 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant K080615 · Endoskeleton TA Interbody Fusion Device (Ibd) · Titan Spine, LLC · 2008K032812 · Endoskeleton TA Vertebral Body Replacement · Orthovita, Inc. · 2003 · recalledK024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 2003K020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled−50+5+10
  1. Root · 5 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 4 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 3 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. 2 generations backK032812 Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc. · 2003 · Recalled
  5. 1 generation backK080615 Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC · 2008
  6. This deviceK083714 Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC · 2009
  7. Descendant · cites it directly · 337 of its ownK102067 Endoskeleton toTitan Spine, LLC · 2010
  8. Descendant · 2 generations on · 267 of its ownK140055 Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC · 2014
  9. Descendant · cites it directly · 265 of its ownK141953 Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC · 2014 · Recalled
  10. Descendant · 2 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
  11. Descendant · cites it directly · 235 of its ownK140348 Interbody CageEisertech, LLC · 2015

Showing 5 of 412 descendants. See all descendants

Descendants cleared per year

2010: 12014: 42015: 22016: 82017: 92018: 162019: 192020: 392021: 382022: 492023: 552024: 632025: 602026: 49
2010high 63 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 412 · See all
  • K102067Endoskeleton toTitan Spine, LLC · 2010 · cites it directly337descendants
  • K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC · 2014 · 2 generations on267descendants
  • 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
  • K140348Interbody CageEisertech, LLC · 2015 · cites it directly235descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−4K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−3K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
−2K032812Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc.20031
−1K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008—
0 (this device)K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009—
+1K102067Endoskeleton toTitan Spine, LLC2010—
+2K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014—
+1K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016—
+1K140348Interbody CageEisertech, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199930
200010
200120
200210
200320
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201440
201520
201680
201790
2018160
2019190
2020390
2021380
2022490
2023550
2024630
2025600
2026490
FIG. 1 — Lineage of K083714, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*P950002Bak Interbody Fusion System
Summary page 1
…s the same indications for use, design, function, and materials used. - The four formerly Class HI predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Br…
Zimmer Spine, Inc.1996—
*P970015Inter Fix Threaded Fusion Device
Summary page 1
…ials used. - The four formerly Class HI predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). In addition, other Class II product…
Sofamor Danek19991
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 1
…nclude the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). In addition, other Class II products including the Titan Spine Endoskeleton® TA IBD (K080615),…
Stryker Spine19961
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…evice (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). In addition, other Class II products including the Titan Spine Endoskeleton® TA IBD (K080615), the Abbott Spine Infix Anterior…
Depuy Spine, Inc.1999—
*K080615Endoskeleton TA Interbody Fusion Device (Ibd)
Summary page 1
…Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). In addition, other Class II products including the Titan Spine Endoskeleton® TA IBD (K080615), the Abbott Spine Infix Anterior Lumbar Spacer (031672) and the Spinal Elements Lucent Interbody Device (K071724) provide featur…
Titan Spine, LLC2008—
*K031672Spinal Concepts, Inc. Infix System
Summary page 1
…e Brantigan Cage (P960025). In addition, other Class II products including the Titan Spine Endoskeleton® TA IBD (K080615), the Abbott Spine Infix Anterior Lumbar Spacer (031672) and the Spinal Elements Lucent Interbody Device (K071724) provide features that are substantially equivalent to the Titan Spine…
Spinal Concepts, Inc.2003—
*K071724Lucent
Summary page 1
…roducts including the Titan Spine Endoskeleton® TA IBD (K080615), the Abbott Spine Infix Anterior Lumbar Spacer (031672) and the Spinal Elements Lucent Interbody Device (K071724) provide features that are substantially equivalent to the Titan Spine Endoskeleton® TT IBD. Performance Testing: The pre-clinic…
Spinal Elements, Inc.2007—

Also cleared against P950002: 34 other devices →

What descends from it? (412)

See all 412

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

NumberDeviceApplicantDecidedDescendants
K102067Endoskeleton toTitan Spine, LLC2010337
K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC2014265
K140348Interbody CageEisertech, LLC2015235
K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106
K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731
K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204

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 8 years and passes through 3 companies; a new generation was cleared every 11 months on median.
  • 4 of the 18 ancestors have a recall of any class.
  • Of its descendants, K102067 (Titan Spine, LLC, 2010) has gone furthest, with 337 descendants of its own.
  • 34 other devices also cite its predicate P950002.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against P950002

34 other devices cite the same predicate.

  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
  • K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
  • K143479Bluefin Interbody SystemTides Medical · 2015

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 MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K083714 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083714: Endoskeleton TT Interbody Fusion Device (Ibd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083714

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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