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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 / March 2026 / K254288

510(k) cleared

Clavicle Fixation System

Skeletal Dynamics, Inc. · Mar 23, 2026 · K254288

FDA cleared the Clavicle Fixation System from Skeletal Dynamics, Inc. on Mar 23, 2026 under K254288, a abbreviated 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 Dec 31, 2025. The decision came 82 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), K252949 (Geminus Volar Distal Radius Plating System).

Questions & Answers

What did FDA clear under K254288?

K254288 is the FDA 510(k) for Clavicle Fixation System, submitted by Skeletal Dynamics, Inc.. FDA's decision date was Mar 23, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Clavicle Fixation System?

Skeletal Dynamics, Inc., based in Miami, FL, is the applicant of record for K254288.

How long did the K254288 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Mar 23, 2026, 82 days later.

← All decisions in March 2026

Sources