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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 / June 2026 / K253046

510(k) cleared

HERA Interlocking Intramedullary Nailing System

ZheJiang Decans Medical Devices Co., Ltd. · Jun 16, 2026 · K253046

FDA cleared the HERA Interlocking Intramedullary Nailing System from ZheJiang Decans Medical Devices Co., Ltd. on Jun 16, 2026 under K253046, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 22, 2025. The decision came 267 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: K253195 (TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems), K252930 (AQUA Laminoplasty Systems), K253130 (Dione PEEK Screw System), K252776 (ARIES Anterior Cervical Plate Systems).

Questions & Answers

What did FDA clear under K253046?

K253046 is the FDA 510(k) for HERA Interlocking Intramedullary Nailing System, submitted by ZheJiang Decans Medical Devices Co., Ltd.. FDA's decision date was Jun 16, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the HERA Interlocking Intramedullary Nailing System?

ZheJiang Decans Medical Devices Co., Ltd., based in Jiaxing, is the applicant of record for K253046.

How long did the K253046 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 16, 2026, 267 days later.

← All decisions in June 2026