510(k) · Cleared
ClearedCascadia Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 24, 2016 as substantially equivalent to K150481 (K2m, Inc., 2015) and 3 other predicates after a 27-day review. Its family tree reaches back 15 generations to 1984. 1 of the 255 devices in its family, counting itself, has a Class I recall. 157 later devices descend from it.
- Decided
- Mar 24, 2016
- Review
- 27 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 97 ancestors in all. 157 later devices descend from it, 5 citing it directly. 1 of the 255 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK160547 Cascadia Interbody SystemK2m · 2016
- Descendant · cites it directly · 122 of its ownK170676 HD Lumbar Interbody SystemHd Lifesciences, LLC · 2017
- Descendant · cites it directly · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
- Descendant · 2 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 2 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 2 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK103169 AleuttianK2m, Inc. · 2011
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK160547 Cascadia Interbody SystemK2m · 2016
Showing 5 of 157 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 157 · See all- K170676HD Lumbar Interbody SystemHd Lifesciences, LLC · 2017 · cites it directly122descendants
- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · cites it directly109descendants
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on108descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 2 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 2 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −3 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −1 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| 0 (this device) | K160547 | Cascadia Interbody System | K2m | 2016 | — |
| +1 | K170676 | HD Lumbar Interbody System | Hd Lifesciences, LLC | 2017 | — |
| +1 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +2 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +2 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +2 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 13 | 1 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 0 |
| 2024 | 28 | 0 |
| 2025 | 30 | 0 |
| 2026 | 29 | 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? (4)
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 |
|---|---|---|---|
| * | K150481 | Cascadia Interbody SystemSummary page 4…): Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX) Predicate Device(s) Primary Predicate: K2M Cascadia Interbody System (K150481) Additional Predicates: K2M Aleutian IBF Spinal System (K082698, K110843, K130699) Device Description The implants consist… | 2015 |
| * | K082698 | Aleutian Ibf SystemSummary page 4…080, Product Code: MAX) Predicate Device(s) Primary Predicate: K2M Cascadia Interbody System (K150481) Additional Predicates: K2M Aleutian IBF Spinal System (K082698, K110843, K130699) Device Description The implants consist of hollow tube structures additively manufactured from titanium allo… | 2009 |
| * | K110843 | Aleutian Spacer SystemSummary page 4…uct Code: MAX) Predicate Device(s) Primary Predicate: K2M Cascadia Interbody System (K150481) Additional Predicates: K2M Aleutian IBF Spinal System (K082698, K110843, K130699) Device Description The implants consist of hollow tube structures additively manufactured from titanium alloy. The de… | 2011 |
| * | K130699 | Aleutian Spinal SystemSummary page 4…MAX) Predicate Device(s) Primary Predicate: K2M Cascadia Interbody System (K150481) Additional Predicates: K2M Aleutian IBF Spinal System (K082698, K110843, K130699) Device Description The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are… | 2013 |
What descends from it? (157)
See all 1575 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 97 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170676 (Hd Lifesciences, LLC, 2017) has gone furthest, with 122 descendants of its own.
- 15 other devices also cite its predicate K150481.
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. 2016, 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 implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 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 autgenous bone graft as intervertebral body fusion devices in
skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1
for the treatment of degenerative disc disease (DDD) with up to Grade 1 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.
https://510kreport.com/device/K160547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160547: 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/K160547
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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