# K252351: UniSpace® TPLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Cg Medtech Co., Ltd.
- Decided: Oct 28, 2025 after 91 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 25 generations back to K841189 (1984). 271 ancestors in all.
No later device cites it as a predicate yet.
1 of 272 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132926: Velofixtm Interbody Fusion System, U&I Corp. (2014) Summary page 5.
- K234119: UniSpace® Stand-Alone C Cage, Innosys Co., Ltd. (2024) Summary page 5.
- K213791: Unispace SA Cervical Cage, Edisoninno Co., Ltd. (2022) Summary page 5.

## Indications for use
The UniSpace® TPLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The UniSpace® TPLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the UniSpace® TPLIF Cage is to be used with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.

Source page: https://510kreport.com/device/K252351
Methodology: https://510kreport.com/methodology