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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 / May 2026 / K261038

510(k) cleared

Xpert PFP

Newclip Technics · May 29, 2026 · K261038

FDA cleared the Xpert PFP from Newclip Technics on May 29, 2026 under K261038, 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 Mar 30, 2026. The decision came 60 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: K261511 (Xpert Ankle), K261191 (Alians Elbow S), K253906 (Xpert Hand), K250767 (Newclip Patient-matched instrumentation non sterile PSI).

Questions & Answers

What did FDA clear under K261038?

K261038 is the FDA 510(k) for Xpert PFP, submitted by Newclip Technics. FDA's decision date was May 29, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Xpert PFP?

Newclip Technics, based in Haute-Goulaine, is the applicant of record for K261038.

How long did the K261038 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on May 29, 2026, 60 days later.

← All decisions in May 2026

Sources