# K160324: Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Evolution Spine, LLC
- Decided: May 5, 2016 after 90 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: 8 generations back to K841189 (1984). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 4.

## Most influential descendants
- K190618: RIGEL PEEK Anterior Cervical Interbody Fusion System (2019), 1 descendant of its own
- K200685: RIGEL 3DR Anterior Cervical Interbody Fusion System (2020), 0 descendants of its own

## Indications for use
This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K160324
Methodology: https://510kreport.com/methodology