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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 / November 2025 / K252949

510(k) cleared

Geminus Volar Distal Radius Plating System

Skeletal Dynamics, Inc. · Nov 13, 2025 · K252949

FDA cleared the Geminus Volar Distal Radius Plating System from Skeletal Dynamics, Inc. on Nov 13, 2025 under K252949, 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 58 days later, inside the 90 FDA-day goal for a 510(k).

Skeletal Dynamics, Inc. has 2 other decisions in the tracker over the last 12 months: K261770 (Suture Button Repair System), K254288 (Clavicle Fixation System).

Questions & Answers

What did FDA clear under K252949?

K252949 is the FDA 510(k) for Geminus Volar Distal Radius Plating System, submitted by Skeletal Dynamics, Inc.. FDA's decision date was Nov 13, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the Geminus Volar Distal Radius Plating System?

Skeletal Dynamics, Inc., based in Miami, FL, is the applicant of record for K252949.

How long did the K252949 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Nov 13, 2025, 58 days later.

← All decisions in November 2025

Sources