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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 / May 2026 / K254077

510(k) cleared

OSSIOfiber® Threaded Trimmable Fixation Nail

OSSIO , Ltd. · May 1, 2026 · K254077

FDA cleared the OSSIOfiber® Threaded Trimmable Fixation Nail from OSSIO , Ltd. on May 1, 2026 under K254077, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 18, 2025. The decision came 134 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

OSSIO , Ltd. has one other decision in the tracker over the last 12 months: K254055 (OSSIOfiber® Suture Anchor).

Questions & Answers

What did FDA clear under K254077?

K254077 is the FDA 510(k) for OSSIOfiber® Threaded Trimmable Fixation Nail, submitted by OSSIO , Ltd.. FDA's decision date was May 1, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the OSSIOfiber® Threaded Trimmable Fixation Nail?

OSSIO , Ltd., based in Caesarea, is the applicant of record for K254077.

How long did the K254077 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on May 1, 2026, 134 days later.

← All decisions in May 2026