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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 / October 2025 / K252758

510(k) cleared

Cannulated Screw and Kirschner (K wire) System

Orthonovis, Inc. · Oct 2, 2025 · K252758

FDA cleared the Cannulated Screw and Kirschner (K wire) System from Orthonovis, Inc. on Oct 2, 2025 under K252758, a special 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 29, 2025. The decision came 34 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Orthonovis, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252758?

K252758 is the FDA 510(k) for Cannulated Screw and Kirschner (K wire) System, submitted by Orthonovis, Inc.. FDA's decision date was Oct 2, 2025, under product code HWC (Screw, Fixation, Bone).

Who makes the Cannulated Screw and Kirschner (K wire) System?

Orthonovis, Inc., based in Palm Coast, FL, is the applicant of record for K252758.

How long did the K252758 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Oct 2, 2025, 34 days later.

← All decisions in October 2025