# K234119: UniSpace® Stand-Alone C Cage

- Pathway: 510(k) (Traditional)
- Applicant: Innosys Co., Ltd.
- Decided: Apr 19, 2024 after 113 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: 24 generations back to K841189 (1984). 270 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 272 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213791: Unispace SA Cervical Cage, Edisoninno Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K252351: UniSpace® TPLIF Cage (2025), 0 descendants of its own

## Indications for use
The UniSpace® Stand-Alone C Cage is a standalone anterior cervical interbody fusion device indicated for 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 UniSpace® Stand-Alone C 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 Cages of the UniSpace® Stand-Alone C Cage must be used with the two internal fixation screws provided. The Cages with = 20° lordosis must be used with an additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine, in addition to the two integrated fixation screws provided. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K234119
Methodology: https://510kreport.com/methodology