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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 / January 2026 / K253867

510(k) cleared

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

ZuriMED Technologies AG · Jan 2, 2026 · K253867

FDA cleared the FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit from ZuriMED Technologies AG on Jan 2, 2026 under K253867, a special 510(k). The device falls under product code OWX, Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 3, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for ZuriMED Technologies AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253867?

K253867 is the FDA 510(k) for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit, submitted by ZuriMED Technologies AG. FDA's decision date was Jan 2, 2026, under product code OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon).

Who makes the FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?

ZuriMED Technologies AG, based in Zurich, is the applicant of record for K253867.

How long did the K253867 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Jan 2, 2026, 30 days later.

← All decisions in January 2026