510(k) Report

510(k) · Cleared

Cleared

Acculif TL-Peek Ibf Cage

K112095510(k) TraditionalCleared Dec 1, 2011132-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coalign Innovations, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 1, 2011 as substantially equivalent to K110270 (Coalign Innovations, Inc., 2011) and 2 other predicates after a 132-day review. Its family tree reaches back 11 generations to 1984. 319 later devices descend from it.

Decided
Dec 1, 2011
Review
132 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. 319 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2008: 3 other ancestors2007: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor2017: 8 descendants cleared2013: 3 descendants cleared2014: 3 descendants cleared2019: 19 descendants cleared2020: 23 descendants cleared2016: 3 descendants cleared2018: 15 descendants cleared2022: 38 descendants cleared2023: 42 descendants cleared2021: 25 descendants cleared2025: 52 descendants cleared2026: 44 descendants cleared2024: 44 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002×2: 2 generations cleared close together, K030833 (2003), K031635 (2003) K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K102293 · Caliber Spacer · Globus Medical, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 4 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 34 descendants3 generations forward: 47 descendants4 generations forward: 63 descendants5 generations forward: 57 descendants6 generations forward: 54 descendants7 generations forward: 36 descendants8 generations forward: 14 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K102293 · Caliber Spacer · Globus Medical, Inc. · 2011K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K031635 · Depuy Acromed VBR System · Depuyacromed · 2003K030833 · Depuy Acromed VBR System · Depuyacromed · 2003K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5+10
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  4. 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  5. 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
  6. This deviceK112095 Acculif TL-Peek Ibf CageCoalign Innovations, Inc. · 2011
  7. Descendant · cites it directly · 199 of its ownK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
  8. Descendant · 2 generations on · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
  9. Descendant · cites it directly · 146 of its ownK123281 Acculif TL-Peek CageCoalign Innovations, Inc. · 2013
  10. Descendant · 3 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
  11. Descendant · cites it directly · 137 of its ownK133813 Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  10. 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  11. 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
  12. This deviceK112095 Acculif TL-Peek Ibf CageCoalign Innovations, Inc. · 2011

Showing 5 of 319 descendants. See all descendants

Descendants cleared per year

2013: 32014: 32016: 32017: 82018: 152019: 192020: 232021: 252022: 382023: 422024: 442025: 522026: 44
2013high 52 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 319 · See all
  • K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · cites it directly199descendants
  • K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 2 generations on159descendants
  • K123281Acculif TL-Peek CageCoalign Innovations, Inc. · 2013 · cites it directly146descendants
  • K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 3 generations on141descendants
  • K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc. · 2014 · cites it directly137descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−7K030833Depuy Acromed VBR SystemDepuyacromed2003—
−6K031635Depuy Acromed VBR SystemDepuyacromed2003—
−5K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−4K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−3K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009—
−2K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009—
−1K102293Caliber SpacerGlobus Medical, Inc.2011—
0 (this device)K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011—
+1K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH20172
+2K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH2017—
+1K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018—
+1K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200120
200310
200720
200830
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201330
201430
201630
201780
2018150
2019190
2020230
2021250
2022380
2023420
2024440
2025520
2026440
FIG. 1 — Lineage of K112095, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K110270Acculif Cage
Summary page 2
…or differences do not impact device performance as compared to the predicates. The AccuLIF TL-PEEK Cage was shown to be substantially equivalent to the AccuLIF LBF Cage (K 110270), the Caliber IBF Cage (K102293), and the SEC IBE and VBR (K093669). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Coalign Innovations, Inc.2011—
*K102293Caliber Spacer
Summary page 2
…ransforaminal approach. Identification of Predicates - AccuLiF IBF Cage (KI 10270) - Caliber IBF Cage (K102293) - SEC IBF and VBR (K093669) Summary of Technological Characteristics AccuLIF TL-PEEK Cage is a…
Globus Medical, Inc.2011—
*K093669Sec Ibf Cage
Summary page 2
…- AccuLiF IBF Cage (KI 10270) - Caliber IBF Cage (K102293) - SEC IBF and VBR (K093669) Summary of Technological Characteristics AccuLIF TL-PEEK Cage is an expandable spacers made from Titanium-6AL-4V ELI alloy that…
Innvotec Surgical, Inc.2010—

Also cleared against K110270: 1 other device →

What descends from it? (319)

See all 319

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017199
K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146
K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137
K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196
K172480icotec Interbody Cage SystemIcotec AG20185
K142023Luna Interbody SystemBenvenue Medical, Inc.20145
K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172
K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162
K193457AUDERE Lumbar Spacer SystemMet One Technologies20201
K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141

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 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, K170503 (Eit Emerging Implant Technologies GmbH, 2017) has gone furthest, with 199 descendants of its own.
  • 1 other device also cites its predicate K110270.

How does its category compare?

All MAX devices

MAX 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

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF® TL-PEEK 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 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…

Read the full statement (121 words)

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF® TL-PEEK 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 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-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage is to be used with autogenous bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K110270

1 other device cites the same predicate.

  • K113465Acculif TL CageCoalign Innovations, Inc. · 2011

More from Coalign Innovations, Inc.

9 FDA decisions under this applicant name. See the company

  • K132505Acculif TL and PL CageCoalign Innovations, Inc. · 20133 recalls
  • K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc. · 2013
  • K130194Acculif XL CageCoalign Innovations, Inc. · 2013
  • K123281Acculif TL-Peek CageCoalign Innovations, Inc. · 2013
  • K123752Acculif TL and PL CageCoalign Innovations, Inc. · 2013

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K112095 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112095: Acculif TL-Peek Ibf Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112095

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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