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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 / K261265

510(k) cleared

Permatage XT Settable Bone Putty

Orthocon, Inc. · Jun 15, 2026 · K261265

FDA cleared the Permatage XT Settable Bone Putty from Orthocon, Inc. on Jun 15, 2026 under K261265, 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 Apr 16, 2026. The decision came 60 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: K261439 (Permatage Flowable, Settable Hemostatic Bone Paste), 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 K261265?

K261265 is the FDA 510(k) for Permatage XT Settable Bone Putty, submitted by Orthocon, Inc.. FDA's decision date was Jun 15, 2026, under product code GXP (Methyl Methacrylate For Cranioplasty).

Who makes the Permatage XT Settable Bone Putty?

Orthocon, Inc., based in Stamford, CT, is the applicant of record for K261265.

How long did the K261265 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Jun 15, 2026, 60 days later.

← All decisions in June 2026

Sources