# K123607: Octane Elevate Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Apr 25, 2014 after 520 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: 14 generations back to K841189 (1984). 73 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071724: Lucent, Spinal Elements, Inc. (2007)
- K120464: Innesis Peek Cage, Bk Meditech, Co., Ltd. (2013). Cleared while this submission was under review Summary page 1.
- K112095: Acculif TL-Peek Ibf Cage, Coalign Innovations, Inc. (2011)
- K123281: Acculif TL-Peek Cage, Coalign Innovations, Inc. (2013). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K220953: ChoiceSpine TigerShark™ M, Modular Interbody System (2022), 0 descendants of its own

## Indications for use
The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to SI in patients with Degenerative Disc Disease (DDD,) with up to Grade I 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 six (6) months of non-operative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K123607
Methodology: https://510kreport.com/methodology