# K190067: Velofix Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: U&I Corporation
- Decided: Feb 4, 2019 after 20 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: 16 generations back to K003155 (2001). 95 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171749: Velofix (tm) Interbody Fusion System, U&I Corporation (2017) Summary page 4.

## Most influential descendants
- K213791: Unispace SA Cervical Cage (2022), 2 descendants of its own
- K234119: UniSpace® Stand-Alone C Cage (2024), 1 descendant of its own
- K252351: UniSpace® TPLIF Cage (2025), 0 descendants of its own

## Indications for use
The Velofix PEEK Cervical Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage. The Velofix PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease(DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K190067
Methodology: https://510kreport.com/methodology