# K181261: Curiteva Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, LLC
- Decided: Jul 9, 2018 after 59 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: 16 generations back to K003155 (2001). 150 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer, Globus Medical, Inc. (2016) Summary page 4.
- K151496: Latitude-C Cervical Interbody Spacer System, Degen Medical (2015) Summary page 4.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 4.

## Most influential descendants
- K213030: Curiteva Porous PEEK Cervical Interbody Fusion System (2023), 3 descendants of its own
- 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 Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 – T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the device.

Source page: https://510kreport.com/device/K181261
Methodology: https://510kreport.com/methodology