# K253583: LUX Expandable Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Xenix Medical
- Decided: Feb 23, 2026 after 98 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: 24 generations back to K841189 (1984). 328 ancestors in all.
No later device cites it as a predicate yet.
1 of 329 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 6.
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical, Ht Medical D.B.A. Xenix Medical (2023) Summary page 6.
- K193258: ProLift Expandable System, Life Spine, Inc. (2020) Summary page 6.

## Indications for use
The LUX Expandable Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). LUX Expandable Lumbar Interbody System implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The LUX Expandable Lumbar Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K253583
Methodology: https://510kreport.com/methodology