510(k) · Cleared
Recalled · Class II · 2016Acculif TL and PL 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 Sep 12, 2013 as substantially equivalent to K123752 (Coalign Innovations, Inc., 2013) after a 31-day review. Its family tree reaches back 14 generations to 1984. 645 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 12, 2013
- Review
- 31 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 14 generations to K841189 (1984). 61 ancestors in all. 645 later devices descend from it, 2 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 backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- This deviceK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- Descendant · cites it directly · 642 of its ownK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- Descendant · 2 generations on · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- Descendant · 3 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- Descendant · 3 generations on · 448 of its ownK152304 Tritanium PL CageStryker · 2015 · Recalled
- Descendant · 3 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
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 backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- This deviceK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
Showing 5 of 645 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 645 · See all- K141217Acculif TL and PL CageStryker Corporation · 2014 · cites it directly642descendants
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · 2 generations on636descendants
- K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 3 generations on469descendants
- K152304Tritanium PL CageStryker · 2015 · 3 generations on448descendants
- K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on390descendants
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 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| 0 (this device) | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| +1 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| +2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +3 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| +3 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| +3 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 17 | 0 |
| 2017 | 39 | 0 |
| 2018 | 42 | 0 |
| 2019 | 55 | 0 |
| 2020 | 68 | 0 |
| 2021 | 57 | 0 |
| 2022 | 69 | 0 |
| 2023 | 83 | 0 |
| 2024 | 83 | 0 |
| 2025 | 68 | 0 |
| 2026 | 57 | 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? (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 |
|---|---|---|---|
| * | K123752 | Acculif TL and PL CageSummary page 2…vations AccuLlE TL and PL Cage are to be used with autogenous bone graft. Identification of Predicates - ActiLIF TL and PL- Cage (K 123752) Sumnmary of Technological Characteristics AccuLIF TL and PL- Cages are expandable spacers made from Titan ium-6AL-_4V ELI alloy… | 2013 |
What descends from it? (645)
See all 6452 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2016 | Class II | Z-2788-2016 | Unknown/Undetermined by firm | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative… |
| Jul 26, 2016 | Class II | Z-2786-2016 | Unknown/Undetermined by firm | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative… |
| Jul 26, 2016 | Class II | Z-2787-2016 | Unknown/Undetermined by firm | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative… |
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 61 ancestors have a recall of any class.
- Of its descendants, K141217 (Stryker Corporation, 2014) has gone furthest, with 642 descendants of its own.
- 5 other devices also cite its predicate K123752.
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 TL and PL Cages are 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 S1. 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…
Read the full statement (127 words)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cages are 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 S1. 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 and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLiF TL and PL Cages are to be used with autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132505: Acculif TL and PL Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132505
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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