WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / November 2025 / K252959

510(k) cleared

WRISTAR MultiAx Distal Radius Kit

Intrauma S.P.A · Nov 12, 2025 · K252959

FDA cleared the WRISTAR MultiAx Distal Radius Kit from Intrauma S.P.A on Nov 12, 2025 under K252959, 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 Sep 16, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Intrauma S.P.A in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252959?

K252959 is the FDA 510(k) for WRISTAR MultiAx Distal Radius Kit, submitted by Intrauma S.P.A. FDA's decision date was Nov 12, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the WRISTAR MultiAx Distal Radius Kit?

Intrauma S.P.A, based in Bruino (To), is the applicant of record for K252959.

How long did the K252959 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Nov 12, 2025, 57 days later.

← All decisions in November 2025