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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 / K253027

510(k) cleared

Anchor with Fiber Wire and Disposable Inserter

Ortobio S.A. · May 6, 2026 · K253027

FDA cleared the Anchor with Fiber Wire and Disposable Inserter from Ortobio S.A. on May 6, 2026 under K253027, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 19, 2025. The decision came 229 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ortobio S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253027?

K253027 is the FDA 510(k) for Anchor with Fiber Wire and Disposable Inserter, submitted by Ortobio S.A.. FDA's decision date was May 6, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Anchor with Fiber Wire and Disposable Inserter?

Ortobio S.A., based in Maringá, is the applicant of record for K253027.

How long did the K253027 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on May 6, 2026, 229 days later.

← All decisions in May 2026