# K180674: EVOL® ha-C Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Cutting Edge Spine, LLC
- Decided: Jun 25, 2018 after 102 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: 14 generations back to K841189 (1984). 83 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150362: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2015) Summary page 5.
- K142026: Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion Device, Spinefrontier, Inc. (2014) Summary page 5.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 5.
- K150321: EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2015) Summary page 5.

## Most influential descendants
- K192497: EVOL ha - D Lateral Interbody Fusion System (2020), 1 descendant of its own
- K250605: EVOL® ha – Hyper C Cervical Interbody Fusion System (2025), 0 descendants of its own
- K200991: EVOL Spinal Interbody System (2020), 0 descendants of its own

## Indications for use
The EVOL® ha – C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha – C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha – C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K180674
Methodology: https://510kreport.com/methodology