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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 / January 2026 / K251896

510(k) cleared

XeliteMed SuperM-Fix Spinal Bone Cement

Xelite Biomed , Ltd. · Jan 28, 2026 · K251896

FDA cleared the XeliteMed SuperM-Fix Spinal Bone Cement from Xelite Biomed , Ltd. on Jan 28, 2026 under K251896, a traditional 510(k). The device falls under product code NDN, Cement, Bone, Vertebroplasty, regulated at 21 CFR 888.3027 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 20, 2025. The decision came 222 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 Xelite Biomed , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251896?

K251896 is the FDA 510(k) for XeliteMed SuperM-Fix Spinal Bone Cement, submitted by Xelite Biomed , Ltd.. FDA's decision date was Jan 28, 2026, under product code NDN (Cement, Bone, Vertebroplasty).

Who makes the XeliteMed SuperM-Fix Spinal Bone Cement?

Xelite Biomed , Ltd., based in New Taipei City, is the applicant of record for K251896.

How long did the K251896 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Jan 28, 2026, 222 days later.

← All decisions in January 2026