510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Cascadia Interbody System

K150481510(k) TraditionalCleared Aug 20, 2015177-day reviewClass II21 CFR 888.3080Recalls 3

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

K2m, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Aug 20, 2015 as substantially equivalent to K082698 (K2m, Inc., 2009) and 8 other predicates after a 177-day review. Its family tree reaches back 14 generations to 1984. 1 of the 556 devices in its family, counting itself, has a Class I recall. 459 later devices descend from it. It has been recalled 3 times.

Decided
Aug 20, 2015
Review
177 days
Class
Class II
Product code
MAX
Recalls
3
Predicates
9

Its longest line of descent runs back 14 generations to K841189 (1984). 96 ancestors in all. 459 later devices descend from it, 16 citing it directly. 1 of the 556 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2012: 3 other ancestors2011: 5 other ancestors2013: 1 other ancestor2010: 2 other ancestors2009: 5 other ancestors2008: 13 other ancestors, 1 with a Class I recall12007: 9 other ancestors2003: 9 other ancestors1999: 2 other ancestors2005: 4 other ancestors2004: 9 other ancestors2002: 7 other ancestors2001: 9 other ancestors1996: 2 other ancestors2000: 1 other ancestor2016: 5 descendants cleared2017: 19 descendants cleared2018: 22 descendants cleared2019: 31 descendants cleared2020: 48 descendants cleared2026: 48 descendants cleared2023: 67 descendants cleared2021: 43 descendants cleared2022: 50 descendants cleared2024: 72 descendants cleared2025: 54 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K051454 · Aleutian Spacer System · K2m, LLC · 2005K063399 · Aleutian Spacer System · K2m, Inc. · 2007K082698 · Aleutian Ibf System · K2m, Inc. · 2009K101302 · Aleutian Ibf System · K2m, Inc. · 2010K103169 · Aleuttian · K2m, Inc. · 2011K130699 · Aleutian Spinal System · K2m, Inc. · 2013K133614 · Aleutian Ibf System · K2m, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 16 other ancestors, 1 with a Class I recall13 generations back: 24 other ancestors4 generations back: 18 other ancestors5 generations back: 9 other ancestors6 generations back: 7 other ancestors7 generations back: 2 other ancestors 1 generation forward: 16 descendants2 generations forward: 70 descendants3 generations forward: 110 descendants4 generations forward: 117 descendants5 generations forward: 91 descendants6 generations forward: 38 descendants7 generations forward: 12 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants K133614 · Aleutian Ibf System · K2m, Inc. · 2014K130699 · Aleutian Spinal System · K2m, Inc. · 2013K103169 · Aleuttian · K2m, Inc. · 2011K101302 · Aleutian Ibf System · K2m, Inc. · 2010K082698 · Aleutian Ibf System · K2m, Inc. · 2009K063399 · Aleutian Spacer System · K2m, Inc. · 2007K051454 · Aleutian Spacer System · K2m, LLC · 2005K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · 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
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK103169 AleuttianK2m, Inc. · 2011
  4. 2 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
  5. 1 generation backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
  6. This deviceK150481 Cascadia Interbody SystemK2m, Inc. · 2015
  7. Descendant · cites it directly · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
  8. Descendant · cites it directly · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  9. Descendant · 2 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
  10. Descendant · cites it directly · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
  11. Descendant · 2 generations on · 163 of its ownK192760 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 7 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 6 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 5 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 4 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  12. 3 generations backK103169 AleuttianK2m, Inc. · 2011
  13. 2 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
  14. 1 generation backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
  15. This deviceK150481 Cascadia Interbody SystemK2m, Inc. · 2015

Showing 5 of 459 descendants. See all descendants

Descendants cleared per year

2016: 52017: 192018: 222019: 312020: 482021: 432022: 502023: 672024: 722025: 542026: 48
2016high 72 (2024) · low 5 (2016)2026

Class I recalls in this family

  • K073202 Ardis Spacer2 generations back · 2008

Most influential descendants

Showing 5 of 459 · See all
  • K160125Cascadia Interbody SystemK2m · 2016 · cites it directly315descendants
  • K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly276descendants
  • K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on227descendants
  • K162264Cascadia Interbody SystemK2m, Inc. · 2016 · cites it directly169descendants
  • K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019 · 2 generations on163descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−7K051454Aleutian Spacer SystemK2m, LLC2005—
−6K063399Aleutian Spacer SystemK2m, Inc.2007—
−5K082698Aleutian Ibf SystemK2m, Inc.2009—
−4K101302Aleutian Ibf SystemK2m, Inc.2010—
−3K103169AleuttianK2m, Inc.2011—
−2K130699Aleutian Spinal SystemK2m, Inc.2013—
−1K133614Aleutian Ibf SystemK2m, Inc.2014—
0 (this device)K150481Cascadia Interbody SystemK2m, Inc.2015—
+1K160125Cascadia Interbody SystemK2m2016—
+1K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+2K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017—
+1K162264Cascadia Interbody SystemK2m, Inc.2016—
+2K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200190
200270
200390
200490
200540
200790
2008131
200950
201020
201150
201230
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201650
2017190
2018220
2019310
2020480
2021430
2022500
2023670
2024720
2025540
2026480
FIG. 1 — Lineage of K150481, 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.

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. #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? (9)

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
*K082698Aleutian Ibf System
Summary page 4
…ervertebral Body Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX) Predicate Device(s) Primary Predicate:  K2M Aleutian IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)…
K2m, Inc.2009—
*K110843Aleutian Spacer System
Summary page 4
…80, Product Code: MAX) Predicate Device(s) Primary Predicate:  K2M Aleutian IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945…
K2m, Inc.2011—
*K113138Aleutian System
Summary page 4
…ct Code: MAX) Predicate Device(s) Primary Predicate:  K2M Aleutian IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Si…
K2m, Inc.2012—
*K130699Aleutian Spinal System
Summary page 4
…MAX) Predicate Device(s) Primary Predicate:  K2M Aleutian IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Signus Mobi…
K2m, Inc.2013—
*K133614Aleutian Ibf System
Summary page 4
…edicate Device(s) Primary Predicate:  K2M Aleutian IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Signus Mobis II ST (…
K2m, Inc.2014—
*K113561TM Ardis Interbody System TM Ardis Interbody System Instrumenation
Summary page 4
…cate:  K2M Aleutian IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Signus Mobis II ST (K141405) Device Description T…
Zimmer Trabecular Metal Technology20122
*K1123164-Web Alif Spinal Truss System (STS)
Summary page 4
…IBF Spinal System (K082698) Additional Predicates:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Signus Mobis II ST (K141405) Device Description The subject submission de…
4-Web, Inc.20111
*K100945Fuse Plif Cafe
Summary page 4
…s:  K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Signus Mobis II ST (K141405) Device Description The subject submission describes the Cascadia Interbody System. The impla…
Advanced Medical Technologies AG2011—
*K141405Mobis II ST Spinal Implant
Summary page 4
…stem (K110843, K113138, K130699, K133614)  Zimmer TM Ardis (K113561)  4WEB STS (K112316)  Advanced Medical Technology Fuse (K100945)  Signus Mobis II ST (K141405) Device Description The subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structu…
Signus Medizintechnik GmbH2014—

Also cleared against K082698: 21 other devices →

What descends from it? (459)

See all 459

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

NumberDeviceApplicantDecidedDescendants
K160125Cascadia Interbody SystemK2m2016315
K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276
K162264Cascadia Interbody SystemK2m, Inc.2016169
K160547Cascadia Interbody SystemK2m2016157
K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105
K153621Juliet® TiSpineart201675
K172941CASCADIA Interbody SystemK2m201852
K163595IMPIX 3D Print CagesMedicrea International SA201728
K163364MOJAVE Expandable Interbody SystemK2m201725
K170055CAPRI Corpectomy Cage SystemK2m201711

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 7, 2021Class IIZ-1697-2021Labeling Change ControlMislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
May 7, 2021Class IIZ-1695-2021Labeling Change ControlMislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
May 7, 2021Class IIZ-1696-2021Labeling Change ControlMislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

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.

  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
  • 14 of the 96 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K160125 (K2m, 2016) has gone furthest, with 315 descendants of its own.
  • 21 other devices also cite its predicate K082698.

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. 2015, 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?

The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by…

Read the full statement (130 words)

The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K082698

21 other devices cite the same predicate.

  • K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K163364MOJAVE Expandable Interbody SystemK2m · 2017
  • K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine · 2016
  • K160125Cascadia Interbody SystemK2m · 2016

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

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/K150481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150481: Cascadia Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150481

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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