# K210573: Velofix SA Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Nov 19, 2021 after 266 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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 K003155 (2001). 142 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 144 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172424: Velofix™ SA Cervical Cage, U&I Corporation (2017) Summary page 4.
- K122872: Intervertebral Body Fusion Device, Dio Medical Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K262726: NeckTune™ SA Cervical Cage (2026), 0 descendants of its own

## Indications for use
The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K210573
Methodology: https://510kreport.com/methodology