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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 / June 2026 / K261439

510(k) cleared

Permatage Flowable, Settable Hemostatic Bone Paste

Orthocon, Inc. · Jun 3, 2026 · K261439

FDA cleared the Permatage Flowable, Settable Hemostatic Bone Paste from Orthocon, Inc. on Jun 3, 2026 under K261439, a traditional 510(k). The device falls under product code MTJ, Wax, Bone as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Apr 30, 2026. The decision came 34 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), K253447 (Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)), K253732 (Permatage Flowable, Settable Bone Paste), K253854 (MONTAGE XT Cranial Cement).

Questions & Answers

What did FDA clear under K261439?

K261439 is the FDA 510(k) for Permatage Flowable, Settable Hemostatic Bone Paste, submitted by Orthocon, Inc.. FDA's decision date was Jun 3, 2026, under product code MTJ (Wax, Bone).

Who makes the Permatage Flowable, Settable Hemostatic Bone Paste?

Orthocon, Inc., based in Stamford, CT, is the applicant of record for K261439.

How long did the K261439 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Jun 3, 2026, 34 days later.

← All decisions in June 2026

Sources