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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 / July 2026 / K260624

510(k) cleared

Arthrex Radial Head Replacement System

Arthrex, Inc. · Jul 30, 2026 · K260624

FDA cleared the Arthrex Radial Head Replacement System from Arthrex, Inc. on Jul 30, 2026 under K260624, a traditional 510(k). The device falls under product code KWI, Prosthesis, Elbow, Hemi-, Radial, Polymer, regulated at 21 CFR 888.3170 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 26, 2026. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System), K253931 (Arthrex Bioabsorbable PushLock Suture Anchors).

Questions & Answers

What did FDA clear under K260624?

K260624 is the FDA 510(k) for Arthrex Radial Head Replacement System, submitted by Arthrex, Inc.. FDA's decision date was Jul 30, 2026, under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer).

Who makes the Arthrex Radial Head Replacement System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K260624.

How long did the K260624 review take?

FDA received the submission on Feb 26, 2026 and issued its decision on Jul 30, 2026, 154 days later.

← All decisions in July 2026