Xenix Medical has announced FDA 510(k) clearance and full commercial launch for its Lux Expandable Lumbar Interbody Fusion System.
Lux is the result of strong market demand for an expandable interbody fusion device that does not compromise the potential for fusion. Whereas traditional expandable devices incorporate bulky expansion mechanisms that occupy space typically reserved for bone graft material, Lux allows for significant post-expansion bone graft packing and features the company’s NanoACTIV surface technology to support postoperative bone growth throughout the device. NanoACTIV, an FDA-designated nanotechnology, comprises proprietary macro-, micro-, and nanoscale features that have been shown in vitro to elicit mesenchymal stem cell differentiation through the osteogenic lineage.
The device also incorporates the company’s signature NeoWave matrix architecture, featuring uniform edge-to-edge porosity and an internal serpentine wall structure that reduces stiffness, point loading, and, thus, the risk of subsidence.
Key Features of the Lux Expandable Interbody Fusion System include:
- Up to 4.5mm of precise post-implantation expansion
- Substantial post-expansion bone graft packing delivered through the inserter into a large endplate-to-endplate graft window
- NanoACTIV surface technology
- Subsidence mitigation through the company’s proprietary NeoWave matrix architecture
