# K130434: Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R - Lordotic

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: May 1, 2013 after 69 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: 11 generations back to K003155 (2001). 31 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082270: Octane Vertebral Body Replacement (VBR) System, Vertiflex, Inc. (2008) Summary page 1.

## Most influential descendants
- K150152: The Octane Straight Intervertebral Fusion Device, Ti Coated (2015), 10 descendants of its own
- K191621: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (2019), 4 descendants of its own
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System (2023), 2 descendants of its own
- K201367: FlareHawk TiHawk9 Interbody Fusion System (2020), 2 descendants of its own

## Indications for use
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S I 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 confinmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K130434
Methodology: https://510kreport.com/methodology