# K180675: Atlas Spine Expandable Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, Inc.
- Decided: Jun 13, 2018 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: 19 generations back to K841189 (1984). 185 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 188 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.
- K121649: Construx Mini Peek TI Spacer System, Orthofix (2012) Summary page 4.
- K130948: C-Fuse Cervical Intervertebral Body Fusion System, Southern Spine, LLC (2013) Summary page 4.
- K162918: Atlas Spine Expandable Interbody System, Atlas Spine, Inc. (2017) Summary page 4.

## Most influential descendants
- K260840: BluEX Cervical Expandable Cage System (2026), 1 descendant of its own
- K262489: BluEX Cervical Expandable Cage System (2026), 0 descendants of its own

## Indications for use
The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K180675
Methodology: https://510kreport.com/methodology