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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253583

510(k) cleared

LUX Expandable Lumbar Interbody System

Xenix Medical · Feb 23, 2026 · K253583

FDA cleared the LUX Expandable Lumbar Interbody System from Xenix Medical on Feb 23, 2026 under K253583, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 17, 2025. The decision came 98 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Xenix Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253583?

K253583 is the FDA 510(k) for LUX Expandable Lumbar Interbody System, submitted by Xenix Medical. FDA's decision date was Feb 23, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the LUX Expandable Lumbar Interbody System?

Xenix Medical, based in Orlando, CA, is the applicant of record for K253583.

How long did the K253583 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Feb 23, 2026, 98 days later.

← All decisions in February 2026