# K150913: Incite Anchored Cervical Interbody Device

- Pathway: 510(k) (Special)
- Applicant: Incite Innovation
- Decided: Apr 30, 2015 after 24 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 12 generations back to K841189 (1984). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130306: Incite Anchored Cervical Interbody Device, Incite Innovation, LLC (2013) Summary page 4.
- K122008: Incite Anchored Cervical Interbody (Aci) Fusion Device, Incite Innovation, LLC (2012) Summary page 4.

## Indications for use
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

Source page: https://510kreport.com/device/K150913
Methodology: https://510kreport.com/methodology