# K082270: Octane Vertebral Body Replacement (VBR) System

- Pathway: 510(k) (Special)
- Applicant: Vertiflex, Inc.
- Decided: Sep 16, 2008 after 36 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K003155 (2001). 30 ancestors in all.
55 later devices descend from it; 3 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070218: Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR), Vertiflex (Tm), Incorporated (2007) 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

## Indications for use
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.

Source page: https://510kreport.com/device/K082270
Methodology: https://510kreport.com/methodology