510(k) · Cleared
ClearedAcculif TL 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 Dec 12, 2011 as substantially equivalent to K110270 (Coalign Innovations, Inc., 2011) and 2 other predicates after a 20-day review. Its family tree reaches back 11 generations to 1984. 1 of the 742 devices in its family, counting itself, has a Class I recall. 718 later devices descend from it.
- Decided
- Dec 12, 2011
- Review
- 20 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 23 ancestors in all. 718 later devices descend from it, 5 citing it directly. 1 of the 742 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 642 of its ownK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- Descendant · 4 generations on · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK113465 Acculif TL CageCoalign Innovations, Inc. · 2011
Showing 5 of 718 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 718 · See all- K121683Acculif TL CageCoalign Innovations, Inc. · 2012 · cites it directly682descendants
- K123752Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · cites it directly676descendants
- K132505Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · 2 generations on645descendants
- K141217Acculif TL and PL CageStryker Corporation · 2014 · 3 generations on642descendants
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · 4 generations on636descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K113465 | Acculif TL Cage | Coalign Innovations, Inc. | 2011 | — |
| +1 | 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 |
| +3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| +4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 18 | 0 |
| 2017 | 45 | 0 |
| 2018 | 46 | 0 |
| 2019 | 64 | 0 |
| 2020 | 77 | 0 |
| 2021 | 63 | 1 |
| 2022 | 71 | 0 |
| 2023 | 86 | 0 |
| 2024 | 89 | 0 |
| 2025 | 75 | 0 |
| 2026 | 68 | 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? (3)
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 |
|---|---|---|---|
| * | K110270 | Acculif Cage | 2011 |
| * | K093669 | Sec Ibf CageSummary page 2…autogenous bone graft. Identification of Predicates - AccuLIF Cage (Ki 10270) - SEC IBF Cage (K093669) - Globus Medical Caliber Spacer (K 102293) Summary of Technological Characteristics AccuLI… | 2010 |
| * | K102293 | Caliber SpacerSummary page 2…- AccuLIF Cage (Ki 10270) - SEC IBF Cage (K093669) - Globus Medical Caliber Spacer (K 102293) Summary of Technological Characteristics AccuLIF TL Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that confo… | 2011 |
What descends from it? (718)
See all 7185 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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K121683 (Coalign Innovations, Inc., 2012) has gone furthest, with 682 descendants of its own.
- 1 other device also cites its predicate K110270.
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 TL 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or…
Read the full statement (121 words)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL 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. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD 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 CoAlign Innovations AccuLIF TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113465: Acculif TL Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113465
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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