# K241396: uCerv Flux™-C 3D Porous Titanium Cervical Interbody

- Pathway: 510(k) (Special)
- Applicant: Ulrich Medical USA, Inc.
- Decided: May 23, 2024 after 7 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: 21 generations back to K841189 (1984). 227 ancestors in all.
No later device cites it as a predicate yet.
1 of 228 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220696: uCerv Flux-C 3D Porous Titanium Cervical Interbody, Ulrich Medical USA (2022) Summary page 4.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 5.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.
- K222004: INTEGRATE -C Interbody Fusion System, Happe Spine (2023) Summary page 5.

## 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 and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. 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/K241396
Methodology: https://510kreport.com/methodology