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 / April 2026 / K260090

510(k) cleared

SMART Osteotomy System

Actis Medical Pty., Ltd. · Apr 10, 2026 · K260090

FDA cleared the SMART Osteotomy System from Actis Medical Pty., Ltd. on Apr 10, 2026 under K260090, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 12, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Actis Medical Pty., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260090?

K260090 is the FDA 510(k) for SMART Osteotomy System, submitted by Actis Medical Pty., Ltd.. FDA's decision date was Apr 10, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the SMART Osteotomy System?

Actis Medical Pty., Ltd., based in Torrensville, is the applicant of record for K260090.

How long did the K260090 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Apr 10, 2026, 88 days later.

← All decisions in April 2026