510(k) · Cleared
ClearedZeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interbody Innovations, Llp · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 5, 2008 after an 88-day review. The FDA summary names its predicate without a number. 843 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
843 later devices descend from it, 9 citing it directly.
- This deviceK081614 Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight…Interbody Innovations, Llp · 2008
- Descendant · cites it directly · 701 of its ownK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · Recalled
- Descendant · 2 generations on · 462 of its ownK131372 Mobis IISignus Medizintechnik GmbH · 2013
- Descendant · 3 generations on · 461 of its ownK141405 Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014
- Descendant · 4 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · cites it directly · 455 of its ownK100889 Endoskeleton TCTitan Spine, LLC · 2010
Showing 5 of 843 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 843 · See all- K090064Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · cites it directly701descendants
- K131372Mobis IISignus Medizintechnik GmbH · 2013 · 2 generations on462descendants
- K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014 · 3 generations on461descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 4 generations on459descendants
- K100889Endoskeleton TCTitan Spine, LLC · 2010 · cites it directly455descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar… | Interbody Innovations, Llp | 2008 | — |
| +1 | K090064 | Eminent Spine Interbody Fusion System | Eminent Spine | 2009 | 1 |
| +2 | K131372 | Mobis II | Signus Medizintechnik GmbH | 2013 | — |
| +3 | K141405 | Mobis II ST Spinal Implant | Signus Medizintechnik GmbH | 2014 | — |
| +4 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 13 | 0 |
| 2014 | 22 | 0 |
| 2015 | 19 | 0 |
| 2016 | 34 | 0 |
| 2017 | 68 | 0 |
| 2018 | 62 | 0 |
| 2019 | 70 | 0 |
| 2020 | 77 | 0 |
| 2021 | 70 | 0 |
| 2022 | 76 | 0 |
| 2023 | 95 | 0 |
| 2024 | 87 | 0 |
| 2025 | 72 | 0 |
| 2026 | 63 | 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 |
|---|---|---|---|
| * | — | previously cleared cervical intervertebral body fusion devices Named without a submission number | |
| * | — | previously cleared lumbar intervertebral body fusion devices Named without a submission number |
What descends from it? (843)
See all 8439 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090064 | Eminent Spine Interbody Fusion System | 2009 | 701 |
| K100889 | Endoskeleton TC | 2010 | 455 |
| K151322 | Amendia Interbody Fusion Devices | 2015 | 226 |
| K151310 | Amendia Interbody Fusion Devices | 2016 | 169 |
| K101363 | VU Cpod Intervertebral Bodu Fusion Device | 2010 | 78 |
| K150847 | Foundation Interbody Devices | 2015 | 29 |
| K140280 | Forticore | 2014 | 9 |
| K160976 | Altus Spine Interbody Fusion System | 2017 | 8 |
| K181589 | Curiteva Lumbar Interbody Fusion System | 2018 | 6 |
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?
- Of its descendants, K090064 (Eminent Spine, 2009) has gone furthest, with 701 descendants of its own.
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. 2008, 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?
Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to…
Read the full statement (430 words)
Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Anterior Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior approach. The Zeus Anterior Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Curved Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a transforaminal approach. The Zeus Curved Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Zeus Straight Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a posterior approach. The Zeus Straight Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081614
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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