# K242829: BluEX Lumbar Expandable Cage System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Oct 23, 2024 after 34 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). 373 ancestors in all.
No later device cites it as a predicate yet.
0 of 374 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213441: PathLoc Lumbar Interbody Fusion Cage System, L&K BIOMED Co., Ltd. (2022) Summary page 5.
- K223474: PathLoc-TA Expandable Lumbar Cage System, L&K BIOMED Co., Ltd. (2023) Summary page 5.
- K231680: AccelFix Lumbar Expandable Cage System, L&K BIOMED Co., Ltd. (2023) Summary page 5.
- K131612: Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek Cages, GS Medical Co., Ltd. (2014) Summary page 5.

## Indications for use
BluEX Lumbar Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. BluEX Lumbar Expandable Cage System is intended for use at either one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The BluEX Lumbar Expandable Cage System must be used with supplementary internal spinal fixation system that are cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (≥20 lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K242829
Methodology: https://510kreport.com/methodology