# K220696: uCerv Flux-C 3D Porous Titanium Cervical Interbody

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA
- Decided: Aug 19, 2022 after 163 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: 20 generations back to K841189 (1984). 202 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 204 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.

## Most influential descendants
- K241396: uCerv Flux™-C 3D Porous Titanium Cervical Interbody (2024), 0 descendants of its own

## Indications for use
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body 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 device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K220696
Methodology: https://510kreport.com/methodology