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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 / K253566

510(k) cleared

Affixus Retrograde Femoral Nailing System

Zimmer, Inc. · Mar 12, 2026 · K253566

FDA cleared the Affixus Retrograde Femoral Nailing System from Zimmer, Inc. on Mar 12, 2026 under K253566, a traditional 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 17, 2025. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zimmer, Inc. has 7 other decisions in the tracker over the last 12 months: K260831 (Z1 Hip System), K261683 (Augment Off-Axis Instrument System), K251840 (Zimmer® Persona® Personalized Knee System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System).

Questions & Answers

What did FDA clear under K253566?

K253566 is the FDA 510(k) for Affixus Retrograde Femoral Nailing System, submitted by Zimmer, Inc.. FDA's decision date was Mar 12, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Affixus Retrograde Femoral Nailing System?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K253566.

How long did the K253566 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 12, 2026, 115 days later.

← All decisions in March 2026