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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 / K261511

510(k) cleared

Xpert Ankle

Newclip Technics · Jul 28, 2026 · K261511

FDA cleared the Xpert Ankle from Newclip Technics on Jul 28, 2026 under K261511, 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 May 7, 2026. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

Newclip Technics has 4 other decisions in the tracker over the last 12 months: K261191 (Alians Elbow S), K261038 (Xpert PFP), K253906 (Xpert Hand), K250767 (Newclip Patient-matched instrumentation non sterile PSI).

Questions & Answers

What did FDA clear under K261511?

K261511 is the FDA 510(k) for Xpert Ankle, submitted by Newclip Technics. FDA's decision date was Jul 28, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Xpert Ankle?

Newclip Technics, based in Haute-Goulaine, is the applicant of record for K261511.

How long did the K261511 review take?

FDA received the submission on May 7, 2026 and issued its decision on Jul 28, 2026, 82 days later.

← All decisions in July 2026

Sources