510(k) · Cleared
ClearedOctane Vertebral Body Replacement (VBR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertiflex, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 16, 2008 as substantially equivalent to K070218 (Vertiflex (Tm), Incorporated, 2007) after a 36-day review. Its family tree reaches back 10 generations to 2001. 55 later devices descend from it.
- Decided
- Sep 16, 2008
- Review
- 36 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003155 (2001). 30 ancestors in all, the oldest K841189 (1984). 55 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations between
- 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 2 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
- 1 generation backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
- This deviceK082270 Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
- Descendant · cites it directly · 47 of its ownK132582 Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 39 of its ownK171489 Acapella Cervical Spacer SystemChoicespine, LP · 2017
- Descendant · 3 generations on · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
- Descendant · 2 generations on · 19 of its ownK152099 Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine · 2016
- Descendant · 4 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
Show all 10 generations
- Root · 10 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations backK012254 VBROsteotech, Inc. · 2001
- 8 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 7 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 5 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 4 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 3 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 2 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
- 1 generation backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
- This deviceK082270 Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc. · 2008
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc. · 2014 · cites it directly47descendants
- K171489Acapella Cervical Spacer SystemChoicespine, LP · 2017 · 2 generations on39descendants
- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · 3 generations on25descendants
- K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine · 2016 · 2 generations on19descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −9 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −8 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −7 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −5 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −4 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −3 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K062132 | Avs PL Peek Spacer System | Stryker Spine | 2006 | — |
| −1 | K070218 | Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) | Vertiflex (Tm), Incorporated | 2007 | — |
| 0 (this device) | K082270 | Octane Vertebral Body Replacement (VBR) System | Vertiflex, Inc. | 2008 | — |
| +1 | K132582 | Exactech Acapella One Cervical Spacer System | Exactech, Inc. | 2014 | 1 |
| +2 | K171489 | Acapella Cervical Spacer System | Choicespine, LP | 2017 | — |
| +3 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
| +2 | K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System | Genesys Spine | 2016 | — |
| +4 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 10 | 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.
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 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? (1)
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 |
|---|---|---|---|
| * | K070218 | Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Summary page 1…uivalent, in whole or in part, to the following commercially available predicate device: OctaneTM Vertebral Body Replacement System - (VertiFlex®, Inc.; K07021 8) 5.4 Device Description Like the predicate Octane TM Vertebral Body Replacement System, or Octane TM VBR Syst… | 2007 |
What descends from it? (55)
See all 553 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K132582 (Exactech, Inc., 2014) has gone furthest, with 47 descendants of its own.
- 1 other device also cites its predicate K070218.
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. 2008, 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?
When used as a vertebral body replacement: The OctaneTM device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The OctaneTM device is designed to restore the biomechanical integrity of the…
Read the full statement (208 words)
When used as a vertebral body replacement:
The OctaneTM device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The OctaneTM device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period The OctaneTM device may be used with allograft or autograft.
When used as an intervertebral body fusion device:
The OctaneTM device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The OctaneTM device is intended to be used with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082270: Octane Vertebral Body Replacement (VBR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082270
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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