# K142586: Captiva Spine FuselOX Cervical IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Captiva Spine
- Decided: May 28, 2015 after 255 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 2 generations back to P980048 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092794: Transcorp Acif System, Transcorp, Inc. (2010) Summary page 4.

## Indications for use
The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Captiva Spine FuseLOX Cervical implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Source page: https://510kreport.com/device/K142586
Methodology: https://510kreport.com/methodology