# K210521: DEXA-C Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine, Inc.
- Decided: Aug 2, 2021 after 160 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: 23 generations back to K841189 (1984). 313 ancestors in all.
No later device cites it as a predicate yet.
1 of 314 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111484: Discovery, Intuitive Spine, LLC (2011) Summary page 4.
- K180364: HD LifeSciences Cervical IBFD System, Hd Lifesciences, LLC (2018) Summary page 4.

## Indications for use
The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K210521
Methodology: https://510kreport.com/methodology