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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 / December 2025 / K253749

510(k) cleared

Affixus® Natural Nail® Proximal Humeral System

Zimmer Switzerland Manufacturing GmbH · Dec 12, 2025 · K253749

FDA cleared the Affixus® Natural Nail® Proximal Humeral System from Zimmer Switzerland Manufacturing GmbH on Dec 12, 2025 under K253749, a special 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 25, 2025. The decision came 17 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zimmer Switzerland Manufacturing GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253749?

K253749 is the FDA 510(k) for Affixus® Natural Nail® Proximal Humeral System, submitted by Zimmer Switzerland Manufacturing GmbH. FDA's decision date was Dec 12, 2025, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Affixus® Natural Nail® Proximal Humeral System?

Zimmer Switzerland Manufacturing GmbH, based in Winterthur, is the applicant of record for K253749.

How long did the K253749 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Dec 12, 2025, 17 days later.

← All decisions in December 2025