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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 / K253854

510(k) cleared

MONTAGE XT Cranial Cement

Orthocon, Inc. · Jan 2, 2026 · K253854

FDA cleared the MONTAGE XT Cranial Cement from Orthocon, Inc. on Jan 2, 2026 under K253854, a special 510(k). The device falls under product code GXP, Methyl Methacrylate For Cranioplasty, regulated at 21 CFR 882.5300 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 3, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Orthocon, Inc. has 4 other decisions in the tracker over the last 12 months: K261265 (Permatage XT Settable Bone Putty), K261439 (Permatage Flowable, Settable Hemostatic Bone Paste), K253447 (Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)), K253732 (Permatage Flowable, Settable Bone Paste).

Questions & Answers

What did FDA clear under K253854?

K253854 is the FDA 510(k) for MONTAGE XT Cranial Cement, submitted by Orthocon, Inc.. FDA's decision date was Jan 2, 2026, under product code GXP (Methyl Methacrylate For Cranioplasty).

Who makes the MONTAGE XT Cranial Cement?

Orthocon, Inc., based in Stamford, CT, is the applicant of record for K253854.

How long did the K253854 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Jan 2, 2026, 30 days later.

← All decisions in January 2026