# K231763: Stable-C Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Aug 21, 2023 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: 22 generations back to K841189 (1984). 337 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 344 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181621: Stable-C Interbody System, Nexus Spine, LLC (2018) Summary page 4.
- K153629: ArcadiusXP C Spinal System, Aesculap Implant Systems, Inc. (2016) Summary page 5.
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System, Genesys Spine (2018) Summary page 5.

## Most influential descendants
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own
- K241467: Stable-C Interbody System (2024), 2 descendants of its own
- K261279: DeltaNEC Interbody System (2026), 0 descendants of its own
- K243934: Stable-L Lumbar Interbody System (2025), 0 descendants of its own

## Indications for use
The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended 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.

Source page: https://510kreport.com/device/K231763
Methodology: https://510kreport.com/methodology