# K103655: Octane-C Interbody Fusion Device System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jun 30, 2011 after 197 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 29 ancestors in all.
48 later devices descend from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 1.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.

## Most influential descendants
- K132582: Exactech Acapella One Cervical Spacer System (2014), 47 descendants of its own
- K171489: Acapella Cervical Spacer System (2017), 39 descendants of its own
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own
- K152099: Genesys Spine Apache® Anchored Cervical Interbody Fusion System (2016), 19 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own

## Recalls of this device
- Jun 15, 2012 · Class II · Z-2120-2012: 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 dev

## Indications for use
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.

Source page: https://510kreport.com/device/K103655
Methodology: https://510kreport.com/methodology