510(k) Report

510(k) · Cleared

Cleared

Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx

K103033510(k) TraditionalCleared Jan 10, 201189-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

Zimmer Trabecular Metal Technology · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jan 10, 2011 as substantially equivalent to K073351 (Spinal Elements, Inc., 2008) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 2001. 505 later devices descend from it.

Decided
Jan 10, 2011
Review
89 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to P980048 (2001). 4 ancestors in all. 505 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2002: 1 other ancestor2014: 3 descendants cleared2011: 2 descendants cleared2018: 28 descendants cleared2012: 1 descendant cleared2024: 76 descendants cleared2021: 47 descendants cleared2019: 33 descendants cleared2015: 2 descendants cleared2013: 1 descendant cleared2022: 52 descendants cleared2016: 7 descendants cleared2023: 72 descendants cleared2020: 53 descendants cleared2017: 21 descendants cleared2026: 50 descendants cleared2025: 57 descendants clearedP980048 · Bak/Cervical (Bak/C) Interbody Fusion System · Sulzer Spine-Tech · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 8 descendants2 generations forward: 18 descendants3 generations forward: 37 descendants4 generations forward: 89 descendants5 generations forward: 116 descendants6 generations forward: 108 descendants7 generations forward: 80 descendants8 generations forward: 35 descendants9 generations forward: 9 descendants10 generations forward: 3 descendants11 generations forward: 2 descendants P980048 · Bak/Cervical (Bak/C) Interbody Fusion System · Sulzer Spine-Tech · 20010+5+10
  1. Root · 1 generation backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
  2. This deviceK103033 Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and…Zimmer Trabecular Metal Technology · 2011
  3. Descendant · cites it directly · 476 of its ownK113561 TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 2012 · Recalled
  4. Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
  5. Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
  6. Descendant · 3 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  7. Descendant · 4 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017

Showing 5 of 505 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 12014: 32015: 22016: 72017: 212018: 282019: 332020: 532021: 472022: 522023: 722024: 762025: 572026: 50
2011high 76 (2024) · low 1 (2012)2026

Most influential descendants

Showing 5 of 505 · See all
  • K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 2012 · cites it directly476descendants
  • K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
  • K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
  • K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on276descendants
  • K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 4 generations on227descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P980048Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech2001—
0 (this device)K103033Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxZimmer Trabecular Metal Technology2011—
+1K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20122
+2K150481Cascadia Interbody SystemK2m, Inc.20153
+3K160125Cascadia Interbody SystemK2m2016—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201310
201430
201520
201670
2017210
2018280
2019330
2020530
2021470
2022520
2023720
2024760
2025570
2026500
FIG. 1 — Lineage of K103033, 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.

Planning a device in ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K073351Crystal
Summary page 2
…rabecular MetaliM Fusion Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include Crystal by Spinal Elements (K07335 1), I3AK/C Interbody Device by Zimmer (P980048), Affinity Anterior Cervical Cage by Medtronic Sof'amor Danek (P000028), and Trabecu…
Spinal Elements, Inc.2008—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 2
…e substantially equivalent to legally marketed predicate devices. The predicate devices include Crystal by Spinal Elements (K07335 1), I3AK/C Interbody Device by Zimmer (P980048), Affinity Anterior Cervical Cage by Medtronic Sof'amor Danek (P000028), and Trabecular Metal Vertebral Body Replacement System b…
Sulzer Spine-Tech2001—
*P000028Affinity (TM) Cage System
Summary page 2
…redicate devices include Crystal by Spinal Elements (K07335 1), I3AK/C Interbody Device by Zimmer (P980048), Affinity Anterior Cervical Cage by Medtronic Sof'amor Danek (P000028), and Trabecular Metal Vertebral Body Replacement System by Zimmer (K070754). The Trabecular Metal Fusion Device has the identic…
Medtronic Sofamor Danek USA, Inc.2002—
*K070754Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155
Summary page 2
…body Device by Zimmer (P980048), Affinity Anterior Cervical Cage by Medtronic Sof'amor Danek (P000028), and Trabecular Metal Vertebral Body Replacement System by Zimmer (K070754). The Trabecular Metal Fusion Device has the identical material as previously cleared predicate devices. The intended use and in…
Zimmer Trabecular Metal Technology2007—

Also cleared against K073351: 26 other devices →

What descends from it? (505)

See all 505

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

NumberDeviceApplicantDecidedDescendants
K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology2012476
K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152
K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131
K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429
K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424
K181621Stable-C Interbody SystemNexus Spine, LLC20187
K142041Porosteon Phusion Metal Cervical CagePorosteon, Inc.20141
K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K113561 (Zimmer Trabecular Metal Technology, 2012) has gone furthest, with 476 descendants of its own.
  • 26 other devices also cite its predicate K073351.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The Trabecular Metal Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Trabecular Metal Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Trabecular Metal Fusion Device is implanted via an anterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K073351

26 other devices cite the same predicate.

  • K191812ADI Cervical Interbody Fusion DeviceAdditive Device, Inc. (Adi) D/B/A Restor3D · 2019
  • K173148ACIFColigne AG · 2017
  • K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017
  • K170297Tranquil Interbody SystemNexus Spine, LLC · 2017
  • K160154ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016
  • K143479Bluefin Interbody SystemTides Medical · 2015

More from Zimmer Trabecular Metal Technology

11 FDA decisions under this applicant name. See the company

  • K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
  • K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology · 2013
  • K120990Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK Trabecular Metal (TM)…Zimmer Trabecular Metal Technology · 20121 recall
  • K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology · 20122 recalls
  • K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K103033 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103033

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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