# K261279: DeltaNEC Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine
- Decided: Jun 22, 2026 after 66 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 29 generations back to K841189 (1984). 566 ancestors in all.
No later device cites it as a predicate yet.
1 of 567 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241467: Stable-C Interbody System, Nexus Spine, LLC (2024) Summary page 5.
- K153629: ArcadiusXP C Spinal System, Aesculap Implant Systems, Inc. (2016) Summary page 6.
- K223627: PreView-III™ Anterior Cervical Plate System, Nexus Spine, LLC (2023) Summary page 6.

## Indications for use
The Nexus Spine DeltaNEC Interbody System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one or two contiguous levels from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment. The system is intended to be used with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K261279
Methodology: https://510kreport.com/methodology