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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 / March 2026 / K253732

510(k) cleared

Permatage Flowable, Settable Bone Paste

Orthocon, Inc. · Mar 13, 2026 · K253732

FDA cleared the Permatage Flowable, Settable Bone Paste from Orthocon, Inc. on Mar 13, 2026 under K253732, a traditional 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 Nov 24, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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)), K253854 (MONTAGE XT Cranial Cement).

Questions & Answers

What did FDA clear under K253732?

K253732 is the FDA 510(k) for Permatage Flowable, Settable Bone Paste, submitted by Orthocon, Inc.. FDA's decision date was Mar 13, 2026, under product code GXP (Methyl Methacrylate For Cranioplasty).

Who makes the Permatage Flowable, Settable Bone Paste?

Orthocon, Inc., based in Stamford, CT, is the applicant of record for K253732.

How long did the K253732 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Mar 13, 2026, 109 days later.

← All decisions in March 2026

Sources