WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253155

510(k) cleared

Fule Metallic Lockable Intramedullary Nail Systems

Beijing Fule Science & Technology Development Co., Ltd. · Jun 17, 2026 · K253155

FDA cleared the Fule Metallic Lockable Intramedullary Nail Systems from Beijing Fule Science & Technology Development Co., Ltd. on Jun 17, 2026 under K253155, 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 26, 2025. The decision came 264 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Fule Science & Technology Development Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K253151 (Fule Interbody Fusion Cage System), K252730 (Fule Spinal Fixation System).

Questions & Answers

What did FDA clear under K253155?

K253155 is the FDA 510(k) for Fule Metallic Lockable Intramedullary Nail Systems, submitted by Beijing Fule Science & Technology Development Co., Ltd.. FDA's decision date was Jun 17, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Fule Metallic Lockable Intramedullary Nail Systems?

Beijing Fule Science & Technology Development Co., Ltd., based in Beijing, is the applicant of record for K253155.

How long did the K253155 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 17, 2026, 264 days later.

← All decisions in June 2026

Sources