510(k) · Cleared
Recalled · Class II · 2012Octane-C Interbody Fusion Device System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jun 30, 2011 as substantially equivalent to K082801 (Us Spine, 2008) and 1 other predicate after a 197-day review. Its family tree reaches back 11 generations to 1984. 48 later devices descend from it. It has been recalled once.
- Decided
- Jun 30, 2011
- Review
- 197 days
- Class
- Class II
- Product code
- ODP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. 48 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK103655 Octane-C Interbody Fusion Device SystemExactech, Inc. · 2011
- 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 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK103655 Octane-C Interbody Fusion Device SystemExactech, Inc. · 2011
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · 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 |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −1 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| 0 (this device) | K103655 | Octane-C Interbody Fusion Device System | Exactech, Inc. | 2011 | — |
| +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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 9 | 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 ODP? 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 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K082801 | Phantom Plus Cage SystemSummary page 1…Fusion Device - Cervical (21 CFR 888.3080, Class 11, Product Code ODP) Legally Marketed Devices to Which Substantial Equivalence Is Claimed PhantomTM Plus Cage System (#K08280 1) BAK Cervical Interbody Fusion Device (#P980048) Device Description This submission proposes a new Cervical Interbody Fusion Sys… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…11, Product Code ODP) Legally Marketed Devices to Which Substantial Equivalence Is Claimed PhantomTM Plus Cage System (#K08280 1) BAK Cervical Interbody Fusion Device (#P980048) Device Description This submission proposes a new Cervical Interbody Fusion System. The Octane-C Interbody Fusion System is des… | 2001 |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132582 | Exactech Acapella One Cervical Spacer System | 2014 | 47 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2012 | Class II | Z-2120-2012 | Labeling False and Misleading | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K132582 (Exactech, Inc., 2014) has gone furthest, with 47 descendants of its own.
- 12 other devices also cite its predicate K082801.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Octane-C Interbody Cervical devices are intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is…
Read the full statement (111 words)
The Octane-C Interbody Cervical devices are intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103655: Octane-C Interbody Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103655
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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