Xenix Medical · Class II · Cleared Feb 23, 2026
| K-number | K253583 |
| Device name | LUX Expandable Lumbar Interbody System |
| Applicant | Xenix Medical |
| Product code | MAX |
| Device class | Class II |
| Decision date | Feb 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The LUX Expandable Lumbar Interbody System is a titanium alloy spinal fusion implant for treating degenerative disc disease in the lumbar spine at one or two levels. It is used with bone graft and supplemental fixation in skeletally mature patients who have failed at least six months of non-operative treatment.
The device incorporates Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface with engineered features at the nanometer level designed to improve bone fixation. The implants are available in multiple footprints and geometric options and are provided sterile with reusable non-sterile instruments for steam sterilization.
ASTM F2077, ASTM F2267, and ASTM F1877 for static and dynamic mechanical testing.
The subject device is substantially equivalent to predicate devices (Rise Spacer, neoWave LS Lumbar Straight, and ProLift Expandable System) with respect to indications, design, materials, function, manufacturing, and performance. The differences in technological characteristics do not raise new or different safety and effectiveness questions.
View the full FDA submission: accessdata.fda.gov