# K143685: Hedgehog Cervical Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Vertera, Inc.
- Decided: Sep 23, 2015 after 273 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: 4 generations back to K072991 (2008). 9 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133218: Crystal ®; Mosaic ®; Vertu ®, Spinal Elements, Inc. (2014) Summary page 4.

## Most influential descendants
- K173030: Vertera Spine Cohere Cervical Interbody Fusion Device (2017), 22 descendants of its own
- K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (2023), 9 descendants of its own
- K222004: INTEGRATE -C Interbody Fusion System (2023), 6 descendants of its own
- K232150: ZSFab Cervical Interbody System (2023), 4 descendants of its own
- K220875: HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (2022), 4 descendants of its own

## Indications for use
The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K143685
Methodology: https://510kreport.com/methodology