510(k) Report

510(k) · Cleared

Cleared

Kodiak C Spinal Implant System

K222806510(k) TraditionalCleared Dec 22, 202297-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

Met One Technologies, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Dec 22, 2022 as substantially equivalent to K161649 (Met 1 Technologies, LLC, 2016) and 5 other predicates after a 97-day review. Its family tree reaches back 22 generations to 1984. 1 of the 331 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Dec 22, 2022
Review
97 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
6

Its longest line of descent runs back 22 generations to K841189 (1984). 329 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 331 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2017: 2 other ancestors2016: 2 other ancestors2015: 3 other ancestors2014: 13 other ancestors2013: 15 other ancestors2012: 13 other ancestors2011: 21 other ancestors2009: 30 other ancestors2008: 47 other ancestors, 1 with a Class I recall12007: 15 other ancestors2010: 16 other ancestors2006: 13 other ancestors2005: 21 other ancestors2003: 18 other ancestors2002: 11 other ancestors2001: 13 other ancestors1999: 3 other ancestors1997: 4 other ancestors1996: 3 other ancestors1993: 2 other ancestors2004: 28 other ancestors2000: 6 other ancestors1998: 3 other ancestors1995: 1 other ancestor1988: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2023: 1 descendant 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) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×3: 3 generations cleared close together, K141217 (2014), K143163 (2015), K143616 (2015) ×3: 3 generations cleared close together, K152304 (2015), K160125 (2016), K162264 (2016) K172009 · Cascadia Interbody System · K2m, Inc. · 2017 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 19 other ancestors3 generations back: 46 other ancestors4 generations back: 80 other ancestors, 1 with a Class I recall15 generations back: 75 other ancestors6 generations back: 45 other ancestors7 generations back: 22 other ancestors8 generations back: 13 other ancestors9 generations back: 3 other ancestors 1 generation forward: 1 descendant K172009 · Cascadia Interbody System · K2m, Inc. · 2017 · recalledK162264 · Cascadia Interbody System · K2m, Inc. · 2016K160125 · Cascadia Interbody System · K2m · 2016K152304 · Tritanium PL Cage · Stryker · 2015 · recalledK143616 · AccuLIF TL and PL Cage · Stryker Corporation · 2015 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · 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. · 1984−20−15−10−50
  1. Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 18 generations between
  3. 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
  4. 2 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
  5. 1 generation backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
  6. This deviceK222806 Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
  7. Descendant · cites it directly · 0 of its ownK230851 Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023
Show all 22 generations
  1. Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  19. 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
  20. 3 generations backK160125 Cascadia Interbody SystemK2m · 2016
  21. 2 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
  22. 1 generation backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
  23. This deviceK222806 Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022

Class I recalls in this family

  • K073202 Ardis Spacer4 generations back · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−21K990148Stackable Cage SystemDepuy Motech Acromed1999—
−20K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−19K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−18K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−17K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−16K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−15K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−14K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−13K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−12K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−11K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−10K121683Acculif TL CageCoalign Innovations, Inc.2012—
−9K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−8K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−7K141217Acculif TL and PL CageStryker Corporation20143
−6K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−5K143616AccuLIF TL and PL CageStryker Corporation20154
−4K152304Tritanium PL CageStryker20151
−3K160125Cascadia Interbody SystemK2m2016—
−2K162264Cascadia Interbody SystemK2m, Inc.2016—
−1K172009Cascadia Interbody SystemK2m, Inc.20173
0 (this device)K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC2022—
+1K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198810
199320
199510
199630
199740
199830
199930
200060
2001130
2002110
2003180
2004280
2005210
2006130
2007150
2008471
2009300
2010160
2011210
2012130
2013150
2014130
201530
201620
201720
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K222806, 1984–2023Source: 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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
*K161649Virtu C Spinal Implant System
Summary page 5
…family of implants that has bodies additively manufactured from Ti-6Al-4V Eli, in compliance with ASTM F3001. VIRTU C Spinal Implant System (Met One Technologies, LLC — K161649) Tranquil Interbody System (Nexxus Spine, LLC — K170297) SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies — K1…
Met 1 Technologies, LLC2016—
*K170297Tranquil Interbody System
Summary page 5
…d from Ti-6Al-4V Eli, in compliance with ASTM F3001. VIRTU C Spinal Implant System (Met One Technologies, LLC — K161649) Tranquil Interbody System (Nexxus Spine, LLC — K170297) SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies — K172446) CASCADIA Interbody System (K2M, Inc. — K172941, K…
Nexus Spine, LLC2017—
*K172446SPIRA-C Open Matrix Cervical Interbody
Summary page 5
…ystem (Met One Technologies, LLC — K161649) Tranquil Interbody System (Nexxus Spine, LLC — K170297) SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies — K172446) CASCADIA Interbody System (K2M, Inc. — K172941, K172009, K162264) Performance Data: Technological Characteris…
Camber Spine Technologies2017—
*K172941CASCADIA Interbody System
Summary page 5
…quil Interbody System (Nexxus Spine, LLC — K170297) SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies — K172446) CASCADIA Interbody System (K2M, Inc. — K172941, K172009, K162264) Performance Data: Technological Characteristics: Conclusion: K222806 Page 3 of 3 The Kodi…
K2m2018—
*K172009Cascadia Interbody System
Summary page 5
…rbody System (Nexxus Spine, LLC — K170297) SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies — K172446) CASCADIA Interbody System (K2M, Inc. — K172941, K172009, K162264) Performance Data: Technological Characteristics: Conclusion: K222806 Page 3 of 3 The Kodiak C Spin…
K2m, Inc.20173
*K162264Cascadia Interbody System
Summary page 5
…tem (Nexxus Spine, LLC — K170297) SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies — K172446) CASCADIA Interbody System (K2M, Inc. — K172941, K172009, K162264) Performance Data: Technological Characteristics: Conclusion: K222806 Page 3 of 3 The Kodiak C Spinal Implan…
K2m, Inc.2016—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230

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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 38 years and passes through 15 companies; a new generation was cleared every 10 months on median.
  • 41 of the 329 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K230851 (Met One Technologies, LLC, 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C…

Read the full statement (188 words)

The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

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

More from Met One Technologies, LLC

4 FDA decisions under this applicant name. See the company

  • K251732Wrist Fracture SystemMet One Technologies, LLC · 2026
  • K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025
  • K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K222806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K222806: Kodiak C Spinal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222806

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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