# K262489: BluEX Cervical Expandable Cage System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Aug 18, 2026 after 29 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: 21 generations back to K841189 (1984). 195 ancestors in all.
No later device cites it as a predicate yet.
1 of 196 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260840: BluEX Cervical Expandable Cage System, L&K BIOMED Co., Ltd. (2026) Summary page 5.

## Indications for use
The BluEX Cervical Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The BluEX Cervical Expandable Cage System is intended for use in anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. The BluEX Cervical Expandable Cage System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. The BluEX Cervical Expandable Cage System is intended to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K262489
Methodology: https://510kreport.com/methodology