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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 / K253130

510(k) cleared

Dione PEEK Screw System

ZheJiang Decans Medical Devices Co., Ltd. · May 27, 2026 · K253130

FDA cleared the Dione PEEK Screw System from ZheJiang Decans Medical Devices Co., Ltd. on May 27, 2026 under K253130, 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 25, 2025. The decision came 244 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ZheJiang Decans Medical Devices Co., Ltd. has 7 other decisions in the tracker over the last 12 months: K253046 (HERA Interlocking Intramedullary Nailing System), K253195 (TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems), K252930 (AQUA Laminoplasty Systems), K252776 (ARIES Anterior Cervical Plate Systems).

Questions & Answers

What did FDA clear under K253130?

K253130 is the FDA 510(k) for Dione PEEK Screw System, submitted by ZheJiang Decans Medical Devices Co., Ltd.. FDA's decision date was May 27, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Dione PEEK Screw System?

ZheJiang Decans Medical Devices Co., Ltd., based in Jiaxing, is the applicant of record for K253130.

How long did the K253130 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on May 27, 2026, 244 days later.

← All decisions in May 2026