# K213030: Curiteva Porous PEEK Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Feb 13, 2023 after 510 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: 17 generations back to K003155 (2001). 184 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181261: Curiteva Cervical Interbody Fusion System, Curiteva, LLC (2018) Summary page 4.
- K173324: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2018) Summary page 4.
- K190025: EVOL® -SI Joint Fusion System, Cutting Edge Spine, LLC (2019) Summary page 4.

## Most influential descendants
- K252205: Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (2026), 0 descendants of its own
- K254061: Curiteva Porous PEEK Cervical Interbody Fusion System (2026), 0 descendants of its own
- K240250: 3D Printed PEEK Interbody System (2024), 0 descendants of its own

## Indications for use
The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion 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 - Ti. 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/K213030
Methodology: https://510kreport.com/methodology