# K222833: Ventana™ C Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: May 19, 2023 after 241 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 K841189 (1984). 131 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 136 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153352: Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System, Spinal Elements, Inc. (2016) Summary page 5.
- K203254: Lucent 3D Spinal System, Spinal Elements, Inc. (2021) Summary page 5.
- K200429: BEE Cages, NGMedical GmbH (2021) Summary page 5.
- K192570: Atlas Spine Expandable Cervical Standalone Interbody System, Atlas Spine, Inc. (2020) Summary page 5.

## Most influential descendants
- 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
Ventana™ C devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems). Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

Source page: https://510kreport.com/device/K222833
Methodology: https://510kreport.com/methodology