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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 / April 2026 / K260934

510(k) cleared

TITAN Nail; APTUS K-Wire System

Medartis AG · Apr 17, 2026 · K260934

FDA cleared the TITAN Nail; APTUS K-Wire System from Medartis AG on Apr 17, 2026 under K260934, 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 Mar 20, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Medartis AG has 2 other decisions in the tracker over the last 12 months: K260761 (APTUS Clavicle System 2.8), K253916 (APTUS Shoulder Proximal Humerus System, PentaLock 3.5).

Questions & Answers

What did FDA clear under K260934?

K260934 is the FDA 510(k) for TITAN Nail; APTUS K-Wire System, submitted by Medartis AG. FDA's decision date was Apr 17, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the TITAN Nail; APTUS K-Wire System?

Medartis AG, based in Basel, is the applicant of record for K260934.

How long did the K260934 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Apr 17, 2026, 28 days later.

← All decisions in April 2026

Sources