510(k) · Cleared
Recalled · Class II · 2021Cascadia Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 14, 2017 as substantially equivalent to K162264 (K2m, Inc., 2016) and 1 other predicate after a 164-day review. Its family tree reaches back 21 generations to 1984. 1 of the 292 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 14, 2017
- Review
- 164 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 21 generations to K841189 (1984). 248 ancestors in all, the oldest K792352 (1979). 43 later devices descend from it, 9 citing it directly. 1 of the 292 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- This deviceK172009 Cascadia Interbody SystemK2m, Inc. · 2017
- Descendant · cites it directly · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
- Descendant · 2 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 2 generations on · 9 of its ownK182987 Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
- Descendant · 3 generations on · 7 of its ownK191489 Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
- Descendant · 3 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 1 generation backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- This deviceK172009 Cascadia Interbody SystemK2m, Inc. · 2017
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 43 · See all- K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · cites it directly24descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 2 generations on12descendants
- K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019 · 2 generations on9descendants
- K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020 · 3 generations on7descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −3 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −1 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| 0 (this device) | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | — |
| +1 | K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018 | — |
| +2 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +2 | K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019 | — |
| +3 | K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | 2020 | — |
| +3 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 21 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 14 | 0 |
| 2008 | 39 | 1 |
| 2009 | 23 | 0 |
| 2010 | 14 | 0 |
| 2011 | 20 | 0 |
| 2012 | 11 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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.
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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162264 | Cascadia Interbody SystemSummary page 4…Intervertebral Fusion Device with Bone Graft, cervical (21 CFR 888.3080, Product Code: ODP) Predicate Device(s) Primary Predicate: K2M Cascadia Interbody System (K162264) Additional Predicates: Nuvasive CoRoent (K141665) Device Description The implants consist of hollow tube structures addit… | 2016 |
| * | K141665 | NuVasive CoRoent SystemSummary page 4…(21 CFR 888.3080, Product Code: ODP) Predicate Device(s) Primary Predicate: K2M Cascadia Interbody System (K162264) Additional Predicates: Nuvasive CoRoent (K141665) Device Description The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are… | 2015 |
What descends from it? (43)
See all 439 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181347 | Aries® Lumbar Interbodies | 2018 | 24 |
| K221858 | ZSFab Lumbar Interbody System | 2022 | 4 |
| K182210 | TiWAVE-L Porous Titanium Lumbar Cage | 2019 | 3 |
| K193370 | Nexxt Matrixx System | 2020 | 2 |
| K222806 | Kodiak C Spinal Implant System | 2022 | 1 |
| K241605 | Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System… | 2024 | 0 |
| K230478 | Acro Composites Interbody System | 2023 | 0 |
| K221172 | FOCUS Interbody System | 2022 | 0 |
| K191408 | Nexxt Matrixx System | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2021 | Class II | Z-1697-2021 | Labeling Change Control | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm |
| May 7, 2021 | Class II | Z-1695-2021 | Labeling Change Control | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm |
| May 7, 2021 | Class II | Z-1696-2021 | Labeling Change Control | Mislabeled 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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 32 of the 248 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181347 (Osseus Fusion Systems, LLC, 2018) has gone furthest, with 24 descendants of its own.
- 6 other devices also cite its predicate K162264.
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. 2017, 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 CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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. The DDD…
Read the full statement (262 words)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s}. These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be nsed with supplemental spinal fixation systems that have been cleared for use in the lumbesacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., > 20°) should be used with anterior supplemental fixation (e.g., &n anterior lumbar plate).
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., > 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172009: 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/K172009
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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