# K191812: ADI Cervical Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D
- Decided: Oct 24, 2019 after 111 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: 1 generation back to K073351 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 4.

## Most influential descendants
- K253894: BMD Titanium Spinal Fusion System (2026), 0 descendants of its own
- K252432: Flex-Z™ Cervical Cage (2026), 0 descendants of its own

## Indications for use
The restor3d 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/K191812
Methodology: https://510kreport.com/methodology