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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 / March 2026 / K253916

510(k) cleared

APTUS Shoulder Proximal Humerus System, PentaLock 3.5

Medartis AG · Mar 16, 2026 · K253916

FDA cleared the APTUS Shoulder Proximal Humerus System, PentaLock 3.5 from Medartis AG on Mar 16, 2026 under K253916, 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 Dec 8, 2025. The decision came 98 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medartis AG has 2 other decisions in the tracker over the last 12 months: K260761 (APTUS Clavicle System 2.8), K260934 (TITAN Nail; APTUS K-Wire System).

Questions & Answers

What did FDA clear under K253916?

K253916 is the FDA 510(k) for APTUS Shoulder Proximal Humerus System, PentaLock 3.5, submitted by Medartis AG. FDA's decision date was Mar 16, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the APTUS Shoulder Proximal Humerus System, PentaLock 3.5?

Medartis AG, based in Basel, is the applicant of record for K253916.

How long did the K253916 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Mar 16, 2026, 98 days later.

← All decisions in March 2026

Sources