510(k) · Cleared
ClearedAcculif XL 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 3, 2013 as substantially equivalent to K123281 (Coalign Innovations, Inc., 2013) and 2 other predicates after a 65-day review. Its family tree reaches back 14 generations to 1984. 1 later device descends from it.
- Decided
- Apr 3, 2013
- Review
- 65 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K841189 (1984). 62 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 1 generation backK123281 Acculif TL-Peek CageCoalign Innovations, Inc. · 2013
- This deviceK130194 Acculif XL CageCoalign Innovations, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK131443 Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc. · 2013
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 1 generation backK123281 Acculif TL-Peek CageCoalign Innovations, Inc. · 2013
- This deviceK130194 Acculif XL CageCoalign Innovations, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −2 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −1 | K123281 | Acculif TL-Peek Cage | Coalign Innovations, Inc. | 2013 | — |
| 0 (this device) | K130194 | Acculif XL Cage | Coalign Innovations, Inc. | 2013 | — |
| +1 | K131443 | Coalign Innovations Acculif XL Ibf Cage | Coalign Innovations, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 MAX? 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123281 | Acculif TL-Peek CageSummary page 2…e CoAlign Innovations AccuL-iF XL Cage is to be used with autogenous bone graft. Identification of Predicates - AccuLIF TL-PEEK Cage (K123281) - AccuL-IF TL Cage (K]2 16835) - AccuLIF TL Cage (KI 11346… | 2013 |
| Kept off the family tree | K216835 | AccuL-IF TL Cage Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3…device performance as compared to the predicates. The AccuLiF XL Cage was shown to be substantially equivalent to the AccuLIF-PEEK Cage (K123281), the AccuLiF TL Cage (K]216835 and KI 13465), and the SEC Interbody Fusion Cage (K093669). DEPARTMENT OF HEALTH & HUMAN SERVICES… | |
| * | K113465 | Acculif TL CageSummary page 2…- AccuLIF TL-PEEK Cage (K123281) - AccuL-IF TL Cage (K]2 16835) - AccuLIF TL Cage (KI 113465) - SEC Interbody Fusion Cage (K093669) Summary of Technological Characteristics AccuLiF XL Ca… | 2011 |
| * | K093669 | Sec Ibf CageSummary page 2…- AccuL-IF TL Cage (K]2 16835) - AccuLIF TL Cage (KI 113465) - SEC Interbody Fusion Cage (K093669) Summary of Technological Characteristics AccuLiF XL Cages are expandable spacers made from Titaniuin-6AL-4V ELI alloy that conf… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131443 | Coalign Innovations Acculif XL Ibf Cage | 2013 | 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 29 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 5 of the 62 ancestors have a recall of any class.
- Of its descendants, K131443 (Coalign Innovations, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K123281.
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. 2013, 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 XL 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 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 XL 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 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 XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130194: Acculif XL Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130194
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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