510(k) · Cleared
ClearedAcculif Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coalign Innovations, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 7, 2011 as substantially equivalent to K093669 (Innvotec Surgical, Inc., 2010) after a 66-day review. Its family tree reaches back 1 generation to 2010. 1 of the 745 devices in its family, counting itself, has a Class I recall. 743 later devices descend from it.
- Decided
- Apr 7, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093669 (2010). 743 later devices descend from it, 2 citing it directly. 1 of the 745 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK093669 Sec Ibf CageInnvotec Surgical, Inc. · 2010
- This deviceK110270 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 · 2 generations on · 676 of its ownK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- Descendant · 3 generations on · 645 of its ownK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 642 of its ownK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
Showing 5 of 743 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 743 · See all- 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 · 2 generations on676descendants
- K132505Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · 3 generations on645descendants
- K141217Acculif TL and PL CageStryker Corporation · 2014 · 4 generations on642descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093669 | Sec Ibf Cage | Innvotec Surgical, Inc. | 2010 | — |
| 0 (this device) | 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 | — |
| +2 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| +3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| +4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K093669 | Sec Ibf CageSummary page 2…mental internal spinal fixation. Additionally, the device may be used with bone graft. Identification of Predicates - SEC IBE Cage (K093669) Summary of Technological Characteristics AccuLIF Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms… | 2010 |
What descends from it? (743)
See all 7432 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2011, 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 CoAlign Innovations AccuLiF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (ODD) at one level or two contiguous levels from L2 to SI1. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These OIDD patients may also have up to Grade I spondylolisthesis or…
Read the full statement (244 words)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLiF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (ODD) at one level or two contiguous levels from L2 to SI1. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These OIDD 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 device is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, CoAlign Innovations AccuLiF 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 LS) 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 CoAlign Innovations AccuLiF 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 device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110270: Acculif Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110270
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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