510(k) · Cleared
ClearedTrabecular Metal (TM) Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 23, 2011 as substantially equivalent to K103033 (Zimmer Trabecular Metal Technology, 2011) and 1 other predicate after a 216-day review. Its family tree reaches back 9 generations to 1984. 52 later devices descend from it.
- Decided
- Nov 23, 2011
- Review
- 216 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K841189 (1984). 20 ancestors in all. 52 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK111119 Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc. · 2011
- Descendant · cites it directly · 24 of its ownK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- Descendant · 2 generations on · 21 of its ownK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- Descendant · 3 generations on · 19 of its ownK200115 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
- Descendant · 3 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · cites it directly · 12 of its ownK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 5 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 4 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 3 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 1 generation backK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
- This deviceK111119 Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc. · 2011
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014 · cites it directly24descendants
- K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018 · 2 generations on21descendants
- K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020 · 3 generations on19descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 3 generations on18descendants
- K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −5 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −4 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −3 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −1 | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K111119 | Trabecular Metal (TM) Fusion Device | Zimmer Spine, Inc. | 2011 | — |
| +1 | K132894 | Optio-C Anterior Cervical System | Zimmer Spine, Inc. | 2014 | — |
| +2 | K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2018 | — |
| +3 | K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2020 | — |
| +3 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +1 | K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 4Web, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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 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 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxSummary page 2…evice. The predicate device selected for use, material, technological characteristics and basic principles of operation was the Zimmer® Trabecular MetalTm Fusion Device (K103033). The predicate device selected for footprint (height) was the Depuy Bengal TM Intervertebral Fusion Device (K081917). The Trabe… | 2011 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 2…on was the Zimmer® Trabecular MetalTm Fusion Device (K103033). The predicate device selected for footprint (height) was the Depuy Bengal TM Intervertebral Fusion Device (K081917). The Trabecular Metal Fusion Device has the identical material as the previously cleared Zimmer Trabecular Metal Fusion Device.… | 2009 |
What descends from it? (52)
See all 526 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132894 | Optio-C Anterior Cervical System | 2014 | 24 |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 2018 | 12 |
| K181621 | Stable-C Interbody System | 2018 | 7 |
| K172480 | icotec Interbody Cage System | 2018 | 5 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | 2024 | 3 |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | 2024 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K132894 (Zimmer Spine, Inc., 2014) has gone furthest, with 24 descendants of its own.
- 7 other devices also cite its predicate K103033.
How does its category compare?
All ODP devicesODP 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
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
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-TI. 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 systemts 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.
https://510kreport.com/device/K111119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111119: Trabecular Metal (TM) Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111119
Report an extraction error
Are you the manufacturer?
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