# K240416: Tranquil-C Interbody System

- Pathway: 510(k) (Special)
- Applicant: Nexus Spine, LLC
- Decided: Mar 12, 2024 after 29 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: 27 generations back to K841189 (1984). 562 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 566 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181483: Tranquil Interbody System, Nexus Spine, LLC (2018) Summary page 4.
- K170297: Tranquil Interbody System, Nexus Spine, LLC (2017) Summary page 5.
- K222833: Ventana™ C Spinal System, Spinal Elements, Inc. (2023) Summary page 5.
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System, Nexus Spine, LLC (2023) Summary page 5.

## Most influential descendants
- 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 Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature 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 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody 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/K240416
Methodology: https://510kreport.com/methodology