# K140864: Veloxtm Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp.
- Decided: Jul 22, 2014 after 110 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: 14 generations back to K003155 (2001). 93 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132926: Velofixtm Interbody Fusion System, U&I Corp. (2014) Summary page 1.
- K122872: Intervertebral Body Fusion Device, Dio Medical Co., Ltd. (2013) Summary page 1.
- K082342: Modification to Capstone Spinal System, Medtronic Sofamor Danek (2008) Summary page 1.

## Most influential descendants
- K171749: Velofix (tm) Interbody Fusion System (2017), 5 descendants of its own
- K190067: Velofix Interbody Fusion System (2019), 3 descendants of its own
- K213791: Unispace SA Cervical Cage (2022), 2 descendants of its own
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K234119: UniSpace® Stand-Alone C Cage (2024), 1 descendant of its own

## Indications for use
The VelotixTM PEEK Cervical Cage is indicated for interveriebral body fusion in skelctally mature patients with degenerative disc disease (DIDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-CJ disc to the C7-T I disc. DOD 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 to facilitate fusion. Patients should have at least six wveeks of non-operative treatment prior to treatment with an intervertebral cag. Thle VelofixTMV PEEK Lumbar Cage is indicated for use wvith aulogenous hone grafl in patients with degenerative disc disease(DDD) at one or two levels for 1,2 to S I. These l)DD patients may also have tip to Grade I Spondylolisthesis or retrolithiesis at the involved levels. OIDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six mionths of non-operative treatment. These devices are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K140864
Methodology: https://510kreport.com/methodology