510(k) · Cleared
ClearedSec Ibf Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innvotec Surgical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 18, 2010 after a 111-day review. The FDA summary names no predicate by number. 1 of the 745 devices in its family, counting itself, has a Class I recall. 744 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
744 later devices descend from it, 9 citing it directly. 1 of the 745 devices in this family, counting this one, has a Class I recall.
- This deviceK093669 Sec Ibf CageInnvotec Surgical, Inc. · 2010
- Descendant · cites it directly · 743 of its ownK110270 Acculif CageCoalign Innovations, Inc. · 2011
- Descendant · cites it directly · 718 of its ownK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
- Descendant · 2 generations on · 682 of its ownK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- Descendant · cites it directly · 676 of its ownK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- Descendant · 2 generations on · 645 of its ownK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
Showing 5 of 744 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 744 · See all- K110270Acculif CageCoalign Innovations, Inc. · 2011 · cites it directly743descendants
- K113465Acculif TL CageCoalign Innovations, Inc. · 2011 · cites it directly718descendants
- K121683Acculif TL CageCoalign Innovations, Inc. · 2012 · 2 generations on682descendants
- K123752Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · cites it directly676descendants
- K132505Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · 2 generations on645descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093669 | Sec Ibf Cage | Innvotec Surgical, Inc. | 2010 | — |
| +1 | K110270 | Acculif Cage | Coalign Innovations, Inc. | 2011 | — |
| +1 | K113465 | Acculif TL Cage | Coalign Innovations, Inc. | 2011 | — |
| +2 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| +1 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| +2 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 20 | 0 |
| 2017 | 49 | 0 |
| 2018 | 50 | 0 |
| 2019 | 66 | 0 |
| 2020 | 79 | 0 |
| 2021 | 65 | 1 |
| 2022 | 72 | 0 |
| 2023 | 88 | 0 |
| 2024 | 90 | 0 |
| 2025 | 76 | 0 |
| 2026 | 69 | 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.
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 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (744)
See all 7449 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110270 | Acculif Cage | 2011 | 743 |
| K113465 | Acculif TL Cage | 2011 | 718 |
| K123752 | Acculif TL and PL Cage | 2013 | 676 |
| K112095 | Acculif TL-Peek Ibf Cage | 2011 | 319 |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular… | 2017 | 199 |
| K172480 | icotec Interbody Cage System | 2018 | 5 |
| K142023 | Luna Interbody System | 2014 | 5 |
| K172756 | Varian cage | 2017 | 1 |
| K130194 | Acculif XL Cage | 2013 | 1 |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K110270 (Coalign Innovations, Inc., 2011) has gone furthest, with 743 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
Intervertebral Body Fusion Device: The lnnvotec Surgical SEC IBF1 Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. ODD is defined as hack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or…
Read the full statement (260 words)
Intervertebral Body Fusion Device: The lnnvotec Surgical SEC IBF1 Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. ODD is defined as hack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC lEE Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the lnnvotec Surgical SEC IBE Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (TI to L-5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC 113E Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC lEEF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innivotec Surgical SEC IBF Cage may be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093669: Sec Ibf Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093669
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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