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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 / February 2026 / K254055

510(k) cleared

OSSIOfiber® Suture Anchor

OSSIO , Ltd. · Feb 24, 2026 · K254055

FDA cleared the OSSIOfiber® Suture Anchor from OSSIO , Ltd. on Feb 24, 2026 under K254055, a traditional 510(k). The device falls under product code MAI, Fastener, Fixation, Biodegradable, Soft Tissue, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 17, 2025. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

OSSIO , Ltd. has one other decision in the tracker over the last 12 months: K254077 (OSSIOfiber® Threaded Trimmable Fixation Nail).

Questions & Answers

What did FDA clear under K254055?

K254055 is the FDA 510(k) for OSSIOfiber® Suture Anchor, submitted by OSSIO , Ltd.. FDA's decision date was Feb 24, 2026, under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue).

Who makes the OSSIOfiber® Suture Anchor?

OSSIO , Ltd., based in Caesarea, is the applicant of record for K254055.

How long did the K254055 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Feb 24, 2026, 69 days later.

← All decisions in February 2026

Sources