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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 / June 2026 / K260761

510(k) cleared

APTUS Clavicle System 2.8

Medartis AG · Jun 5, 2026 · K260761

FDA cleared the APTUS Clavicle System 2.8 from Medartis AG on Jun 5, 2026 under K260761, 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 Mar 9, 2026. The decision came 88 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: K260934 (TITAN Nail; APTUS K-Wire System), K253916 (APTUS Shoulder Proximal Humerus System, PentaLock 3.5).

Questions & Answers

What did FDA clear under K260761?

K260761 is the FDA 510(k) for APTUS Clavicle System 2.8, submitted by Medartis AG. FDA's decision date was Jun 5, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the APTUS Clavicle System 2.8?

Medartis AG, based in Basel, is the applicant of record for K260761.

How long did the K260761 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Jun 5, 2026, 88 days later.

← All decisions in June 2026

Sources