510(k) Report

510(k) · Cleared

Cleared

Endoskeleton TA Interbody Fusion Device (Ibd)

K080615510(k) TraditionalCleared Jun 17, 2008105-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 Jun 17, 2008 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) and 3 other predicates after a 105-day review. Its family tree reaches back 4 generations to 2001. 1 of the 576 devices in its family, counting itself, has a Class I recall. 564 later devices descend from it.

Decided
Jun 17, 2008
Review
105 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K003275 (2001). 11 ancestors in all, the oldest K841189 (1984). 564 later devices descend from it, 7 citing it directly. 1 of the 576 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors1996: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1984: 1 other ancestor2014: 7 descendants cleared2020: 58 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2017: 19 descendants cleared2015: 6 descendants cleared2013: 1 descendant cleared2018: 28 descendants cleared2021: 51 descendants cleared, 1 with a Class I recall12012: 1 descendant cleared2016: 14 descendants cleared2022: 61 descendants cleared2019: 38 descendants cleared2024: 83 descendants cleared2026: 58 descendants cleared2025: 67 descendants cleared2023: 68 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 28 descendants3 generations forward: 76 descendants4 generations forward: 111 descendants5 generations forward: 107 descendants6 generations forward: 113 descendants, 1 with a Class I recall17 generations forward: 81 descendants8 generations forward: 26 descendants9 generations forward: 9 descendants10 generations forward: 4 descendants11 generations forward: 2 descendants K032812 · 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 · recalled0+5+10
  1. Root · 4 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 3 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 2 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. 1 generation backK032812 Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc. · 2003 · Recalled
  5. This deviceK080615 Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC · 2008
  6. Descendant · cites it directly · 480 of its ownK101310 VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010
  7. Descendant · 2 generations on · 460 of its ownK133286 Midline (TM)Centinel Spine, Inc. · 2014
  8. Descendant · 2 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
  9. Descendant · cites it directly · 412 of its ownK083714 Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC · 2009
  10. Descendant · 3 generations on · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015

Showing 5 of 564 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 12012: 12013: 12014: 72015: 62016: 142017: 192018: 282019: 382020: 582021: 512022: 612023: 682024: 832025: 672026: 58
2009high 83 (2024) · low 1 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 564 · See all
  • K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2010 · cites it directly480descendants
  • K133286Midline (TM)Centinel Spine, Inc. · 2014 · 2 generations on460descendants
  • K141942Midline II TICentinel Spine, Inc. · 2014 · 2 generations on459descendants
  • K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC · 2009 · cites it directly412descendants
  • K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · 3 generations on368descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−3K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−2K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
−1K032812Endoskeleton TA Vertebral Body ReplacementOrthovita, Inc.20031
0 (this device)K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008—
+1K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010—
+2K133286Midline (TM)Centinel Spine, Inc.2014—
+2K141942Midline II TICentinel Spine, Inc.2014—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199920
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201110
201210
201310
201470
201560
2016140
2017190
2018280
2019380
2020580
2021511
2022610
2023680
2024830
2025670
2026580
FIG. 1 — Lineage of K080615, 2001–2026Source: 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.

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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*P950002Bak Interbody Fusion System
Summary page 1
…eared devices and has the same indications for use, design, function, and materials used. The four predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015) and the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the…
Zimmer Spine, Inc.1996—
*P970015Inter Fix Threaded Fusion Device
Summary page 1
…function, and materials used. The four predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015) and the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Titan Spine Endoskeleton TA® VBR (K032812). Performance T…
Sofamor Danek19991
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 1
…ude the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015) and the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Titan Spine Endoskeleton TA® VBR (K032812). Performance Testing: The pre-clinical testing performed indicated that the…
Stryker Spine19961
*K032812Endoskeleton TA Vertebral Body Replacement
Summary page 1
…50002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015) and the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Titan Spine Endoskeleton TA® VBR (K032812). Performance Testing: The pre-clinical testing performed indicated that the Endoskeleton TA® Interbody Fusion Device is adequa…
Orthovita, Inc.20031

Also cleared against P950002: 34 other devices →

What descends from it? (564)

See all 564

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

NumberDeviceApplicantDecidedDescendants
K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480
K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412
K111626Endoskeleton (R) TasTitan Spine, LLC2011273
K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC2014265
K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143
K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106
K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 4 of the 11 ancestors have a recall of any class.
  • Of its descendants, K101310 (Theken Spine, LLC, 2010) has gone furthest, with 480 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. 2008, 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 TA® Interbody Fusion Device 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 may 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 use 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/K080615 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080615: Endoskeleton TA Interbody Fusion Device (Ibd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080615

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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