# K172424: Velofix™ SA Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Nov 22, 2017 after 104 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003155 (2001). 141 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 147 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.
- K122872: Intervertebral Body Fusion Device, Dio Medical Co., Ltd. (2013) Summary page 4.
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE), Zimmer Spine, Inc. (2015) Summary page 4.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 4.
- K132999: Cervical Stand Alone System, Orthofix, Inc. (2014) Summary page 4.
- K161280: Cervical Stand Alone System, Orthofix, Inc. (2016) 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
- K210573: Velofix SA Cervical Cage (2021), 1 descendant of its own
- K262726: NeckTune™ SA Cervical Cage (2026), 0 descendants of its own
- K252351: UniSpace® TPLIF Cage (2025), 0 descendants of its own

## Recalls of this device
- Jan 30, 2019 · Class II · Z-1823-2020: The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw

## 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 autogenous 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/K172424
Methodology: https://510kreport.com/methodology