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 Jul 5, 2012 as substantially equivalent to K113465 (Coalign Innovations, Inc., 2011) and 1 other predicate after a 28-day review. Its family tree reaches back 12 generations to 1984. 682 later devices descend from it.
- Decided
- Jul 5, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K841189 (1984). 59 ancestors in all. 682 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 1 generation backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK121683 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
- Descendant · 5 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 1 generation backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
Showing 5 of 682 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 682 · See all- 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
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 5 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −1 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| 0 (this device) | 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 | — |
| +5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 18 | 0 |
| 2017 | 42 | 0 |
| 2018 | 45 | 0 |
| 2019 | 61 | 0 |
| 2020 | 73 | 0 |
| 2021 | 60 | 0 |
| 2022 | 71 | 0 |
| 2023 | 85 | 0 |
| 2024 | 83 | 0 |
| 2025 | 69 | 0 |
| 2026 | 61 | 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? (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.
What descends from it? (682)
See all 6822 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 59 ancestors have a recall of any class.
- Of its descendants, K123752 (Coalign Innovations, Inc., 2013) has gone furthest, with 676 descendants of its own.
- 4 other devices also cite its predicate K113465.
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. 2012, 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?
The.CoAlign Innovations AccuLIF TL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients wit 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).…
Read the full statement (116 words)
The.CoAlign Innovations AccuLIF TL Cage is indicated for intervertebral body fusion with
autogenous bone graft material in patients wit 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 wit
autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121683: 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/K121683
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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