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 / February 2026 / K253764

510(k) cleared

ENOS Software Guided External Fixation System

Disior, Ltd. · Feb 26, 2026 · K253764

FDA cleared the ENOS Software Guided External Fixation System from Disior, Ltd. on Feb 26, 2026 under K253764, a traditional 510(k). The device falls under product code OSN, Software For Diagnosis/Treatment, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 25, 2025. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Disior, Ltd. has one other decision in the tracker over the last 12 months: K250023 (SMART PCFD).

Questions & Answers

What did FDA clear under K253764?

K253764 is the FDA 510(k) for ENOS Software Guided External Fixation System, submitted by Disior, Ltd.. FDA's decision date was Feb 26, 2026, under product code OSN (Software For Diagnosis/Treatment).

Who makes the ENOS Software Guided External Fixation System?

Disior, Ltd., based in Helsinki Uusimaa, FL, is the applicant of record for K253764.

How long did the K253764 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Feb 26, 2026, 93 days later.

← All decisions in February 2026